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http://www.arx.com - http://www.arx.com
21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application. |
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Wolter Kluwers MediRegs - http://www.mediregs.com
Compliance and risk management software solutions for your business. Specializing in healthcare billing compliance, ERM (enterprise risk management), food, drug and medical device compliance, and grant management compliance. |
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Waters Corporation - http://www.21cfrpart11.com
A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures. |
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FDALive.com - http://www.fdalive.com/
Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CDs, videotapes and transcripts available. |
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Emergo Group, Inc. - http://www.emergogroup.com
Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia. |
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ERA Consulting Group - http://www.eraconsulting.com
Specialist services for pharmaceutical companies in regulatory affairs, including the development/registration of biotechnology and biological medicinal products, with offices in Europe and the United States. |
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Fulcrum Pharma - http://www.fulcrumpharma.com/
European consultancy with experience in all aspects of regulatory affairs and pharmacovigilance. |
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Masy Systems - http://www.masy.com/
Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies. |
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Octagon Research Solutions, Inc. - http://www.octagonresearch.com
Offers a suite of services that span the entire clinical research and development lifecycle. |
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Kemic Bioresearch - http://www.kemic.com
Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology). |
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D & D Consulting LLC - http://www.ddcvalidation.com
D & D Consulting LLC provides validation, commissioning, and quality services to the pharmaceutical, biotechnology, and medical device industries. |
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Medical Device Consultants, Inc. (MDCI) - http://www.mdci.com
Provides worldwide regulatory, clinical, and quality assurance consulting services to medical device and diagnostic product manufacturers to meet US, Canadian, and European requirements. |
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PharmaReady - http://www.pharmaready.com/
PharmaReady™ is a fully integrated web-based eDMS and eCTD Submissions Solution Suite. |
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Tarius A/S - http://www.tarius.com/
Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events. |
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Chemgineering - http://www.chemgineering.com
German consulting and engineering group with a focal on challenging capital investment projects in the Life Sciences industries. |
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Entrinsik - http://www.entrinsik.com
Their employee development solutions provide for compliance management and learning management; our Gxp compliance Edition is "validation ready", ideal for GxP compliance training requirements in the pharmaceutical or medical device industries. |
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Seraphim Life Sciences Consulting LLC - http://www.seraphimlifesciences.com/
Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors. |
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Azilon Corporation - http://azilon.com
Provides compliance solutions for healthcare and financial sectors. |
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Reg123.com - http://www.reg123.com
Reg123.com is a portal for the new medicinal product development community with a focus on regulatory affairs and the pharmaceutical drug development process. |
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Lorenz LIfe Sciences - http://www.lorenz.cc
Regulatory affairs eCTD software and service for electronic submission management for companies with USA FDA, Canada, Europe, EMEA, Japan PMDA agencies. |
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Obelis European Authorized Representative Center - http://www.obelis.net/
Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium. |
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Qserve Group - http://www.qservegroup.com/
Qserve® Group B.V provides CE Marking, quality management system implementation and auditing of ISO 13485, (pre)clinical evaluation, product market approval (e.g. CE/EU and FDA/USA) and production registration as well as other regulatory services. |
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Innovative Consultancy Services - http://www.pharmaceutical-consultancy.com
Indian pharmaceutical consultant company providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and validation services. |
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Reg-info.com - http://www.reg-info.com/
A collection of links to websites with information relating to regulatory affairs and the development of medicines. |
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Infonetica - http://www.gcptraining.org.uk
GCP online training course provides a comprehensive guide to the basic principles, regulations, and guidelines of ICH good clinical practice. |
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GMP Online Consultancy - http://www.gmp-online-consultancy.com
European-based, Good Manufacturing Practice (GMP) online consultancy. |
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Biologics Consulting Group - http://www.biologicsconsulting.com
FDA regulatory experience and provide regulatory application support, "mock" FDA inspections, vendor and clinical trial site audits, statistical services, clinical trial design/review, and preparation of responses to FDA compliance actions. |
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Online GCP Training - http://www.onlinegcp.com
Online good clinical practice training. |
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ASG Inc. - http://www.asg-inc.com
Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro. |
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Inflexxion, Inc. - http://www.navippro.com
Turnkey solution for risk management needs that integrates sensitive surveillance with sophisticated signal detection, signal verification, and targeted prevention and intervention programs. |
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CanReg Inc. - http://www.canreginc.com
Regulatory specialists provide strategy, submissions, and support for global clients. |
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Drumbeat Dimensions Inc. - http://www.drumkey.com
Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance. |
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http://www.bestechconsulting.biz - http://www.bestechconsulting.biz
Consulting services guides medical companies through the FDA and CE compliance processes to ensure their business success. Provide solutions for regulatory compliance, product safety, litigation support and design and development of medical devices. |
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HDM Corp. - http://www.hdmcorp.com
Offers Internet-based HIPAA privacy and confidentiality training software for payers, providers and academia as well as HIPAA-compliant medical billing software for providers. |
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PinneyAssociates - http://www.pinneyassociates.com/
Pinney Associates brings science and public health expertise to pharmaceutical, consumer healthcare, and biologics clients in risk management, over-the-counter switch, and marketing strategy. |
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http://www.isoxp.com/ - http://www.isoxp.com/
Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available. |
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Cyton Biosciences Ltd. - http://www.cyton.com
European regulatory affairs consultancy providing specialist product development and registration services. |
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Lachman Consultants - http://www.lachmanconsultants.com
Offers consultancy services to prevent and resolve compliance problems and to develop strategies for the submission and approval of drugs, biologics, and devices. |
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Marion Weinreb and Associates, Inc. - http://gmpsrus.com
Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs. |
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Perseus Partners - http://www.perseus.be
Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements. |
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SeerPharma - http://www.seerpharma.com.au
SeerPharma is a professional consultancy specializing in the delivery of technical compliance and validation, QA knowledge, and GMP training solutions to the pharmaceutical, medical device and biotechnology industries. |
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http://www.adneurope.com - http://www.adneurope.com
Compliance for electronic record management for FDA regulated companies. |
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http://www.aclairo.com - http://www.aclairo.com
Aclairo is a drug development consultancy, based in the Washington DC area, focusing on preclinical toxicology, pharmacology, regulatory affairs issues, and U.S. Agent services to non-U.S. biopharmaceutical companies. |
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PRISYM ID Compliant Barcode & Labeling - http://www.prisymidinc.com
21 CFR Part 11 validated barcode and labeling solutions for pharmaceutical and medical device manufacturers. |
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Validation Technologies, Inc. - http://www.validation.org/
Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries. |
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MDI Consultants. Inc. - http://www.mdiconsultants.com
A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries. |
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http://www.ndareg.com - http://www.ndareg.com
NDA is a European regulatory affairs and patient safety consultancy. |
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Aitheras, LLC. - http://www.aitheras.com/
Offers validation, ERP/CRM, testing, and enterprise efficiency services for medium and large scale organizations from Rockville, Maryland. |
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Ceutical Labs - http://www.ceuticallabs.com
Provide infrastructure to small to medium sized businesses in pharmaceutical, medical device, nutraceutical, pet, and cosmetic industries, including product development, project management, validation, quality, regulatory affairs, IT, sales, and marketing. |
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Coastal Consulting Group, Ltd. - http://www.coastalcg.com
Medical device regulatory affairs, clinical studies, quality systems, and documentation services. |
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Pensa Technology Solutions Inc. - http://www.gmps.com/
21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems. |
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Tecno-med Ingenieros - http://www.tecno-med.es/
Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices. |
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Phoenix Regulatory Associates, Ltd - http://www.phoenixrising.com
Regulatory affairs consultants based in the Washington DC metro area with the industry and FDA expertise to aid small to large pharmaceutical and medical device companies. |
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Validation in Partnership Ltd - http://www.vipltd.co.uk
Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services. |
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Global Regulatory - http://www.globalregulatory.com/
Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets. |
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Pharmalink Consulting - http://www.pharmalinkconsulting.co.uk
For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC |
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CIMCON Software, Inc. - http://www.part11solutions.com
Document, drawing and spreadsheet management solutions for US FDA compliant pharma manufacturing units. |
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Al Weisenborn Medical Device Consulting - http://www.qsrhelp.com
Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services. |
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http://devicecompliance.com/ - http://devicecompliance.com/
Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety. |
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Wainwright Associates - http://wainwrightassociates.co.uk
UK based regulatory affairs consultants offering a wide range of services to international companies in the pharmaceutical, medical device, nutritional and healthcare industry. |
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Regulatory Affairs Associates LLC - http://www.regaffairs.net
RAA (regulatory affairs consultancy) |
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http://www.comply.co.il - http://www.comply.co.il
Software packages for quality assurance processes such as management of the documentation center, employee training records, environmental monitoring, deviations, CAPA, stability studies, and trends analysis. |
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IPMB GmbH - http://www.ipmb.eu/
Institute for regulatory affairs and pharmaceutical services located in Germany. |
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Pharmaceutical Regulatory Services, Inc. - http://www.pharmregservices.com
Provide clinical and regulatory support of all phases of global drug development with operations in over 80 countries on all continents. |
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Quality Implementation Services Inc. - http://www.qisfdaconsultants.com
Provides consulting services to pharmaceutical, medical device, and life sciences industries in quality assurance, quality control, and regulatory affairs compliance. |
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ComplianceFDA, Inc. - http://www.complianceFDA.com/
FDA warning letter and CFR categorization and search database. |
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Coding Compliance Solutions - http://codingcompliance.com
Consulting firms specializing in supporting hospitals, physicians and attorneys address complex coding issues. Major emphasis on working with counsel in support of fraud and abuse allegations from third-party payers. |
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eCTDusergroup - http://www.ectd.it
Italian professional community on e-ctd and e-submission topics. |
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Applied Regulatory Consulting Limited - http://www.appliedregulatory.com
Provides regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, training, regulatory agency interactions, and regulatory submissions. |
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Regulatory Affairs Syndicator - http://regulatory.schwoebel.net
This website syndicates material for regulatory affairs professionals. Feeds are obtained from a variety of global resources about the US Food and Drug Administration. |
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Jouhou Koukai Services LLC - http://www.jouhoukoukai.com
Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market. |
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Q-NET LLC - http://www.ce-authorizedrepresentative.eu
EU authorized representative service in accordance with the EU medical device directive and EU machinery directive. Also act as FDA US agent for foreign establishments. |
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GLP Quality Consulting, LLC - http://www.glpqualityconsulting.com
Consulting services for the pharmaceutical, biotech, and agricultural chemistry industries. |
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Global Regulatory Services - http://www.globalregulatoryservices.com
Regulatory affairs services for the pharmaceutical, herbal, and biotech industries. |
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WellKang LLC - http://www.510k.us/510k-submission-procedure.html
Regulatory affairs consultancy specializing in medical devices. |
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http://www.qarad.com - http://www.qarad.com
Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories. |
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Ehrreich Consulting, Inc. - http://www.regsolutions.com
Regulatory consultants expediting FDA approval by solving tough scientific, clinical, and regulatory issues which may arise pre- and post-submission. |
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FarmavitaR+ - http://www.farmavitar.com
Professional network of regulatory affairs consultants and professionals. |
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http://abrimed.com - http://abrimed.com
Regulatory affairs consultants for ISO, GMP, and FDA compliance |
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Global Quality Alliance, LLC - http://www.gqaconsulting.com
Team of GMP consultants and quality auditors that provide consulting, auditing, and training to the pharmaceutical, biotechnology, API, dietary supplement, pharmaceutical compounding, and medical device industries. |
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xfda consulting - http://www.xfda.com
xFDA consulting provides services to small and mid-sized pharmaceutical and device companies including biotechnology in the areas of preclinical, clinical, CMC and regulatory. |
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MEDIcept - http://www.medicept.com
MEDIcept is a vertically integrated consulting firm specializing in contract engineering, quality assurance, and regulatory consulting. |
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UK Medical Device Consultancy - http://www.medicaldeviceconsultancy.co.uk
Provides medical device companies with business development services from regulatory affairs, quality systems to strategic reviews, marketing advice, strategic market research, product management from concept to market, business planning, distribution and partner search. |
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Di Renzo Regulatory Affairs - http://www.direnzo.biz
Provides regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations. Rome, Italy. |
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TRAC Services - http://www.tracservices.co.uk/
A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry. |
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Validation Systems, Inc. - http://www.validationsystems.com
We provide contract and consulting services in the following areas: validation and technical services (IQ OQ PQ protocols and validation master plans VMP), quality systems development, laboratory services, environmental monitoring, and water testing. |
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Validation and cGMP Compliance - http://www.cqionline.com/
Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters. |
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PRS Clinical Ltd - http://www.prs-clinical.com
Provider of clinical trial services |
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eCTD Office - http://www.ectdoffice.com/
A suite of three integrated NeeS/eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS/eCTD submissions. |
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Doctor Device - http://www.doctordevice.com/
Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.S. commerce. Expert witness for neurological devices. |
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Estrin Consulting Group, Inc. - http://yourfdaconsultant.com/
ECG serves the medical device, pharmaceutical and cosmetic firms on FDA submissions, meetings and compliance related issues. Founder and President: Norman F. Estrin, Ph.D. Regulatory Affairs Certified. |
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MarcM Consulting Canada - http://www.marcmconsulting.ca
Regulatory affairs consultants assisting pharmaceutical and related industries with product registrations, GMP inspections, ISO conformity, clinical research/trials, bioequivalence studies, and DMF preparations. Regulatory and business development services offered in English, Portuguese, and Spanish. |
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The Tamarack Group - http://www.thetamarackgroup.net
Tamarack Group consultants (Charmaine Sutton, Carol DeSain) provide regulatory approvals and compliance services (GMP, QSR) for product development and manufacturers of medical products (US FDA, EU, Canada). |
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Qware Riskmanager - http://www.risk-online.com
A management system for the risk analysis for producers of medical devices and in-vitro-diagnostics according to the world wide valid standard DIN EN ISO 14971. |
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Strategic Compliance International, Inc. - http://www.sci-nc.com
SCI, Inc. specializes in regulatory compliance consulting for biologics, medical devices and drug companies. |
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The Matthews Consultancy - http://www.tmconsultancy.com/
European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development. |
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SMB Validation and Compliance Services Group - http://www.smbvalidation.com/
SMB Group is designed to get your equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled with a minimum of interference with operations. |
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The Horizon Phoenix Group LLC - http://www.horizonphoenix.biz
Quality/regulatory consultants for medical device, pharmaceutical and biotechnology industries. Services include: CE Marking, Authorized European Representative, USFDA, 510ks, PMAs, US Agent and Canadian Licenses. |
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RegulatoryPro.com - http://www.regulatorypro.com
RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries. |
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21 CFR Consulting - http://www.21cfrconsulting.com/
Privately held virtual company in Encinitas, California, offering quality and risk assessments, remediation, IT system validation and training for FDA regulated industries. |
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CMAC Consultancy - http://www.cmacusa.com
Provides services like documentation and change control, validation and qualification execution, calibration and preventive maintenance, GXP training and implementation, project administration and commissioning, as well as, IT services/operation management. |
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Sigma Biomedical - http://www.sigmabiomedical.com
Sigma Biomedical supports biomedical research and medical device development by providing custom solutions. |
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Compliance Associates - http://www.complianceassociates.ca
Dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements. |
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Pharmacovigilance - http://www.pharmacovigilanceunit.com
Consultancy based in Italy that offers scientific services and regulatory affairs for the pharmaceutical industry. |
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Pharmaceutical Development Group - http://www.pharmdevgroup.com
Dr. Cheryl Blume and staff provide pharmaceutical and FDA regulatory consulting services including, but not limited to, development of pharmacovigilance assessment programs, pharmacokinetic protocols, non-clinical protocols and preparation for GCP/GLP and cGMP inspections. |
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http://www.sagaem.it - http://www.sagaem.it
Sagaem is an Italian consultancy providing regulatory affairs and business development services to pharmaceutical companies wishing to approach the Italian market or enlarge their existing business in Italy. |
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Thermal Compliance Ltd - http://www.thermalcompliance.co.uk
Thermal mapping and autoclave validation |
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Evolve Technologies, Inc - http://www.ehipaatraining.com
Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans. |
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CL Tech Inc. - http://www.qualityleader.com
Provide qualification, compliance, regulatory, training, and validation services to pharmaceutical, medical device, and biotechnology industries. Specializing in facility, equipment and Part 11 validations. |
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Independent Pharma Consultants - http://www.ipcons.co.uk
Independent Pharma Consultants is a UK based regulatory affairs consultancy that offers a range of services. |
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Arham Consultants.com - http://arhamconsultants.com
Pharma regulatory affairs consultants based in New Delhi, India for the department of DCGI - Drugs Controller General of India - and NPPA - National Pharmaceutical Pricing Authority. |
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http://www.omsbar.com/ - http://www.omsbar.com/
OMSBAR provides consultancy services in regulatory affairs, product registrations, export certification, training, project management and product development, quality management, verification and validation, and maintains a core staff of experienced medical device personnel. |
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Computer System Validation - http://www.ComputerSystemValidation.com
Consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. |
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Carexa Inc. - http://www.carexa.com
Consultants providing strategy and services for drug development and regulatory affairs. |
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Cabridge Regulatory Services - http://www.cambreg.co.uk
Specialists in the field of pharmaceutical regulatory affairs. |
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Kobridge Consulting Ltd - http://www.kobridgeconsulting.com
Korean consultants to medical device companies for CE marking, Canadian approvals, and FDA compliance. |
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Spherelink FDA Consulting - http://spherelink.com
Spherelink provides FDA consulting and international trade consulting between Asia and the United States. |
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http://www.exalon.com - http://www.exalon.com
Specialized on eCTD submissions. |
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QualiMedd - http://www.qualimedd.com
An independent UK management consultancy working within the areas of product development specializing in medical devices and in-vitro diagnostics. |
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Joe Schwoebel, BSEE, MBA - http://www.schwoebel.net
Offers consulting services related to product planning, clinical study, regulatory affairs and reimbursement strategy. Includes resume, certifications and press releases, and FDA approvals. |
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IMI Consulting GmbH - http://www.imiconsulting.com
IMI Consulting GmbH is specialized in advising and implementing: strategy development, global marketing, business development, licensing, and mergers and acquisitions. |
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Oracle Consulting Group - http://www.fdamaze.com
Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training |
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Karandikar Laboratories Pvt. Ltd. - http://www.laboratorytestingindia.com
Test and calibration laboratory located in India. |
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PAT toolkit - http://www.pattoolkit.com
Provides information on the FDA’s Process Analytical Technology (PAT) Initiative and outlines a software package to help pharmaceutical manufacturers implement this initiative. |
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Regulatory Bureau "Cratia" - http://www.bureaucracy.com.ua
Consulting and active assistance in registration (regulatory affairs) and clinical trials of medicinal products, API's, supplements, and medical devices in CIS countries (Ukraine, Russian Federation, Kazakhstan, Moldova, Byelorussia). |
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Acerna Inc. - http://www.acerna.ca
GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues. |
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http://mediqol.com - http://mediqol.com
Offers a range of medical device consultancy services throughout Europe (including CE marking, regulatory and clinical trials management). |
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TopPharm Consulting - http://www.regulatory-affairs.pl/
Regulatory affairs consultancy in Poland and EU (MRP, DCP, national, medical devices, food supplements, and scientific dossier consultation). |
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IDEC Validation Ltd - http://www.idecvalidation.com/
Provider of Quality and Compliance services to the Pharmaceutical / Biotechnology sector. Primarily assist organisations in the CSV field satisfy Regulatory and Compliance requirements. IVL has field knowledge in the implementation of compliance solutions. |
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Brandt Research Consulting LLC - http://www.brandtconsulting.us
Providing a wide range of consulting services in GCP, GLP and GMP compliance. |
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Quality First International Ltd. - http://www.qualityfirstint.com
QFI is a European based consultancy providing CE marking services, EU Authorised Representative Programme, Microbiology Advisory Programme, QMS implementation, Conformity Assessment support and compliance audits |
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Pharmaceutical registration in EU and CEE - http://www.pharmaregist.com
Offers drug and medical devices registration and maintenance in EU. |
| |
QMR, LLC - http://www.qmr-llc.com
Medical device, pharmaceutical, diagnostic, and other life science quality assurance and regulatory affairs consulting services. |
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Thomas E. Colonna Ph.D./J.D. & Associates - http://www.tcolonna.com
Provides consulting services in the scientific and regulatory aspects of a wide range of medical devices with particular expertise in the areas of in vitro diagnostics and biotechnology-based products. |
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Kamm & Associates - http://www.fda-consultant.com
Specializes in assisting businesses with compliance of GMP/QSR regulations. |
| |
Biotech Consultant LLC - http://www.biotech-consultant.com
Biotech Consultant LLC provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, pharmacogenomics, analyte specific reagent (ASR) regulatory compliance, and proteomics), medical device software (including bioinformatics), CPT coding reimbursement, and biotechnology-based products. |
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GCP Solutions - http://mysite.verizon.net/sisbill1/gcp.htm
GCP Solutions provides good clinical practice consulting services. |
| |
Shafi Consultancy - http://www.shaficonsultancy.com/
Firm specializing in providing SAS training and expertise in working with clinical trials. |
| |
FDA Compliance Solutions - http://www.fdacompliancesolutions.com
Consultants providing a full range of FDA compliance services, including computer system validation, software validation, process validation, pharmaceutical validation and consulting. |
| |
VTS Consultants, Inc. - http://www.vtsconsultants.com
Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries. |
| |
HIPAA Exams, Inc. - http://www.hipaaexams.com
Online HIPAA training course and testing for healthcare professionals. |
| |
ARx Pharma, Inc. - http://www.arxpharma.com/
Provide scientific and regulatory CMC consulting services to the global pharmaceutical and biopharmaceutical industry through strategic design and implementation of different aspects. |
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Lionpharm Regulatory Consulting GmbH - http://www.lionpharm.com
Lionpharm is an independent consultancy company providing all kind of regulatory affairs services covering the whole life-cycle of medicinal products in Europe. |
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Perkins and Perkins - http://www.perkinsandperkins.net
FDA consultants Perkins and Perkins, Inc. conduct mock FDA audits to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation. |
| |
Coda Corp. USA - http://www.codacorpusa.com/
Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide. |
| |
Buphycon Consultancy - http://www.buphycon.com
Provide scientific and regulatory affairs consultancy to investors, individual investigators, and the biopharmaceutical industry operating in the field of vaccinology. |
| |
Alphapharma Consulting - http://www.alphapharma.com/aboutus.html
Good Manufacturing Practice (GMP) consulting services to the pharmaceutical industry. |
| |
CIEX, Incorporated - http://www.ciexinc.com
CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design. |
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Regulatory Affairs Consulting - http://www.newdrugapprovals.com
Regulatory affairs consulting services to the pharmaceutical and related industries. |
| |
CompliaPharm, LLC - http://www.compliapharm.com
Quality and regulatory compliance consulting services for the life sciences industry. |
| |
Leonard T. Flynn - http://www.drflynnconsulting.com
An independent regulatory and scientific consultant who provides assistance to pharmaceutical, health product and chemical manufacturers for them to meet the requirements of government agencies. |
| |
Harpaz Consulting Services - http://www.harpazconsulting.com/
Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide. |
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Delphi Consulting - http://www.delphiconsulting.com
Delphi Consulting Group provides US FDA consulting services for medical devices. |
| |
Medcon Taiwan, Inc. - http://www.medcon-taiwan.com
A Taiwan-based regulatory affairs consultant to the medical and life science industry |
| |
NJK & Associates, Inc. - http://njkconsulting.com
NJK & Associates are a collaborative group of industry consultants serving the medical device and IVD industry. |
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Creative Consultants - http://www.creativeconsultantsindia.com
India-based agency engaged in preparation of registration dossiers for export of drug formulations. We also prepare clinical trial reports, training manuals, drug master files, SOPs, and validation reports. |
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Med Pharma Solutions, LLC - http://medpharmasolutions.com/
Provides on-site compliance consulting services including factory acceptance testing, commissioning, IQ/OQ/PQ's, validation and qualification services to the FDA regulated industries. |
| |
Shay Ginsbourg - http://www.ginsbourg.com
Israeli consultant experienced in various regulatory certifications, as well as, verification and validation of software and medical devices. |
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Zeta Consulting - http://zeta.jo
Informatics oriented organization involved in multiple validation and implementation projects in the pharmaceutical and clinical trials industries. |
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Arvin Shroff Associates LLC - http://www.arvinshroff.com
Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies. |
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Draco Associates Ltd. - http://www.dracoassociates.com
Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other regulated products. |
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DRW Research & Information Services, LLC - http://www.drw-research.com
Provides regulatory affairs research and information for the healthcare industry. |
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Validation Online Net - http://www.validation-online.net
Generic downloadable documents that are cGMP compliant. |
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RegIntel Ltd. - http://www.regintel.com
Provides international regulatory solutions to the pharmaceutical and biologics industries. |
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Lewis CMC Consulting - http://www.lewiscmc.com
Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services. |
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Pharma-EU s.r.o. - http://www.pharma-eu.com
Provides consulting services to pharmaceutical regulatory affairs professionals in the European Union. |
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Gamp Forum - http://www.gampforum.com
Bio-Pharma professionals forum. |
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Atubra Inc. - http://atubra.com
Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies. |
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Quality Vectors - http://www.quality-vectors.com
Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries. |
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ISOComp, Inc. - http://www.isocomp.com/
ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies. |
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R. A. Q .A. Associates - http://www.raqaassociates.com
R.A.Q.A. Associates provides FDA and ISO related consulting services to medical device and pharmaceutical companies. We specialize in helping firms with regulatory and cGMP problems, constructing and implementing entirely new quality and regulatory systems or improving existing systems. |
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Samarind Regulatory Management Software - http://www.samarindrms.co.uk
Samarind RMS is a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions. |
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http://www.cro.nu - http://www.cro.nu
CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies. |
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Chestnut Solutions Inc. - http://chestnutsolutions.com/
Offers global regulatory strategies, document management, electronic submissions and CTD filings to pharmaceutical and biotech companies and contract research organizations in Canada, Europe and the US. |
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CATS Consultants GmbH - http://www.catsconsultants.com
EU regulatory affairs and preclinical/toxicological consulting. |
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American Technical Consultants - http://www.atccorp.net/
Consultant group specializing in providing services on FDA compliance issues to the food, drug and cosmetic industry. |
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FDC Services, LLC - http://fdcservices.com
A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries. |
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Jim Colyn & Associates Quality Consultants, LLC - http://www.jcolynconsulting.com
Consulting services targeting compliance and performance for human tissue processors, tissue recovery organizations, organ procurement organizations, eye banks, reproductive banks, and medical device manufacturers. |
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Regulatory Pharma - http://www.regulatorypharma.com/
Regulatory Pharma provides regulatory affairs consultancy services (registration and reimbursement of medicinal products (Rx, OTC, plant origin), medical devices, food supplements, and cosmetics) in Poland and Romania. |
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Veirup Consult - http://www.veirupconsult.dk
Danish regulatory affairs consultancy |
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http://www.qsitemed.com - http://www.qsitemed.com
Qsite is a consulting group focused on the medical device industry. Services include advice on international regulatory affairs, clinical affairs, biostatistics, and global quality assurance. |
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Innovative Automation - http://www.21cfrpart11compliance.com/
Part 11 compliance software solutions designed for MS-Excel, MS-Word, electronic laboratory notebook, and file replication. |
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SimPILy Read - http://www.simpilyread.co.uk/
Offers patient information leaflet readability tests, compliance reviews and advice on leaflet improvement for international pharmaceutical and traditional herbal medicines industries. |
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Mandell Horwitz Consultants LLC - http://mandellhorwitzconsulting.com
Regulatory and scientific consulting for medical devices and other FDA-regulated products. |
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THINQ Compliance Ltd. - http://www.thinqcompliance.com/
The integration of services and software to provide competitive compliance, quality advocacy and thought leadership. |
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Quality Solutions - http://www.validationprofessionals.com
Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries. |
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Tumont Limited - http://www.tumont.co.uk
Specializes in providing cGxP equipment and software validation support to pharmaceutical laboratories in UK. They can provide plans, protocols, reports, SOPs, inventories and training on a fixed cost basis. |
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Smith and Associates - http://www.fdaconsultants.com/
A consulting firm specializing in regulatory affairs for medical device manufacturing. |
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International Regulatory Business Consultants, L.L.C. - http://irb-c.com
Providing scientific and regulatory consultant services to the global pharmaceutical, nutritional supplement, medical device, and diagnostic product industries |
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CLINSTEP LLC - http://www.clinstep.com
Multilingual regulatory affairs consultancy for medical devices, pharmaceuticals and diagnostic devices. |
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Universal Regulatory Inc. - http://www.universalregulatory.com
Specializing in regulatory strategy development, preparation, and review of regulatory submissions. |
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IHL Consulting Group, Inc. - http://www.ihlconsulting.com
FDA consultants based in Atlanta Georgia for the drug, biotechnology, biologics, and medical device industries. |
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ProSource - http://www.prosourcedev.com/
ProSource has developed a portfolio of software solutions. |
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Karlton CMC Consulting - http://www.karltoncmcregulatory.net
Specializing in pharmaceutical CMC regulatory affairs providing long range strategic planning, technical writing, and in-house regulatory affairs training. |
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PharmaCon GmbH - http://www.pharma-con.ch/
Consulting in regulatory strategy for medicinal products. |
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www.delcornosas.com/ - http://www.delcornosas.com/
Services to the pharmaceutical industry, aimed at obtaining the appropriate authorizations in Italy and Europe. |
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Custom Business Development & Management Technology - http://www.cbdmt.com
Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis. |
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KRM Associates - http://www.krm-associates.com/
Regulatory due diligence advisory practice for the health care industry specialized in domestic & international regulatory requirements for medical products (e.g. medical devices, pharmaceutical, tissue products, and in vitro diagnostics). |
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The Gnomon Group, LLC - http://thegnomongroup.com
Regulatory affairs consulting services based in Research Triangle Park NC covering the pharmaceutical and biotech industries, including regulatory strategy, FDA submissions, safety review, foreign company filings, and marketing review. |