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Other links at Business Services > Consulting > Medical and Life Sciences > Regulatory Affairs |
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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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R. A. Q .A. Associates
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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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Cro.nu
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CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies.
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Coda Corp. USA
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Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.
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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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