Guidance Archives

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Translating Study Reports – A GLP Draft Guidance

Introduction: In a global community, studies are often conducted by testing facilities located outside of the United States of America, including countries such as Brazil,...

Compliance: Framing Success Utilizing PIC/S and EU GMP

Introduction PIC/S was founded in 1995 as an extension of PIC (Pharmaceutical Inspection Convention). They are a non-binding cooperative arrangement between 56 different Regulatory Authorities....

Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline

To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality...