Good Manufacturing Practice

We have conducted inspections on API (drug substance) and Formulation (drug product) companies on a worldwide basis, with the emphasis on IMPs (Investigational Medicinal Products) for EC/USA trials.

We work with subcontractors to ensure quality manufacture by review of both Master Batch Records and Specifications, and follow up with review of completed batch information, including QA release on behalf of clients. We do not provide a QP service for EC release.

  • We have responsibility for QA/CMC (Chemistry Manufacturing and Control) project management for current oncology therapies and have worked on other indications.

  • We have audited API manufacturers in EC, USA and Australia.

  • We have been continuously involved in QA and release procedures with formulation, packaging and labeling of IMPs in EC/USA since 2000.

  • We have set up systems for shipment and inventory control of IMPs across all continents.

  • We regularly liaise between clinical/CMC groups to ensure limited inventory clinical supply is maintained.

  • We review and approve all manufacturing documentation for IMP supplies.

  • We assist in compilation of regulatory submissions (IND/CTA) and Amendments

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