Quality Systems
We operate in compliance with cGMP in all areas, from our product development projects through to commercial manufacturing, packaging operations and commercial support services.
- FDA and MHRA-approved for the manufacture, packaging and release of pharmaceutical products
- MHRA-approved for the manufacture and release of clinical drug product
- Extensive regulatory authority and client audit history
- State-of-the-art manufacturing and packaging facilities constructed and operated to achieve a minimum of Grade D / Class 100,000 environmental standard
- Dedicated Quality Compliance personnel, monitoring adherence to cGMP in all operations
- Comprehensive Qualified Person (QP) services, including release of clinical and commercial drug product to market and first site of EU Import Testing
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