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Online source to assess and market medical devices & find consultants
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FDA Consultants
Need help with FDA Compliance? We employ ex-FDA Inspectors.
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Med Device Compliance LMS
FDA-Authored QSR Courses and Part 11-Validated Web Platform
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Directory Sites
Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance.
www.drumkey.com
Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements.
www.bioreg.com
Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
www.qsrhelp.com
Regulatory affairs consulting services to the pharmaceutical and related industries.
www.newdrugapprovals.com
Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission.
www.regsolutions.com
Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.
www.codacorpusa.com
Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community.
www.liquent.com
Thomas E. Colonna Ph.D./J.D. & Associates
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.
www.tcolonna.com
Daniel Kamm, P.E., C.Q.A., is the Principal Engineer of Kamm & Associates. He is an electronics engineer and regulatory affairs executive with over thirty years experience in the medical device business, specializes in Good Manufacturing Practices auditing, consulting, and training.
www.fda-consultant.com
Provides expert technical consultation in the areas of FDA Related Activities, Quality Control / Quality Assurance, Validation / Qualification, Stability / Expiration Dating, Research and Development of Pharmaceutical Dosage Forms, New Facilities Construction for R&D and Production to the Pharmaceutical, Biotechnology, Device, Diagnostic and Allied Health Industries
www.lachmanconsultants.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.
www.drflynnconsulting.com
German consultant for the pharmaceutical industry.
www.medpharmtec.de
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.
codingcompliance.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.
www.entrinsik.com
German consulting group experienced in different licensing procedures of drugs and medicinal products at the national and European level. Website is available in both German and English.
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