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Other links at Business Services > Consulting > Medical and Life Sciences > Regulatory Affairs |
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QuadraMed
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A pharmaceutical regulatory company with european affiliated offices specializing in marketing authorizations, european clinical trials, mutual recognition procedures, and orphan drug designations.
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Acerna Inc.
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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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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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AQA
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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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Perkins and Perkins
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FDA consultants Perkins and Perkins, Inc. conduct mock FDA audits to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation.
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