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Other links at Business Services > Consulting > Medical and Life Sciences > Regulatory Affairs |
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Bio-Reg Associates, Inc.
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Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements.
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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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Biotech Consultant LLC
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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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PAT toolkit
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Provides information on the FDAa£á?s Process Analytical Technology (PAT) Initiative and outlines a software package to help pharmaceutical manufacturers implement this initiative.
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