Quality
CMC Documentation

Our QA team has over 50 years of cumulative experience, with a proven compliance record in the pharmaceutical industry and can support clients with CMC, DMF and IND submissions. For additional information, please contact our project management team.

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Quality
Quality and Compliance

Excellent Compliance Track Record –  The compliance track record at our facility in Cincinnati, Ohio, USA is excellent, demonstrated by numerous successful inspections by FDA and by our customers.  Following our registration with FDA as API supplier [for both oligonucleotides and small molecules], Girindus received in 2007 and 2010 unannounced systems audits by the FDA that […]

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