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Quality Management System for a Clinical-Stage Biopharmaceutical Company


A clinical-stage biopharmaceutical company requested that Avoca perform an in-depth review and assessment of its Quality Management System (QMS).

The project objectives were to identify and document gaps and to provide guidance in the design and development of a comprehensive QMS that would complement the company’s existing QMS.

The company also requested that Avoca review the requirements and implications of ICH E6 (R2) and their bearing on the company’s current processes and recommend modifications required to achieve compliance.

Because the company was a member of the Avoca Quality Consortium (AQC), Avoca’s project team leveraged AQC leading practices, where applicable.

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