Our facility was one of the first of its type to be approved by the MHRA for the production APIs to GMP standards for both phase I and phase II clinical studies.

• API manufacture and release
• Process validation
• MHRA approved service to European and US standards
• Proven record of clinical material production

Onyx has dedicated GMP kilo laboratories for API production in addition to several flexible isolation rooms for intermediate scale GMP work. Our facilities include class 100,000 clean rooms and a variety of vessel sizes up to 50 litre. We also offer complete technology transfer to manufacturing scale. An extensive range of analytical support, expert regulatory guidance and advice is provided as standard.

Onyx is the ideal partner for your GMP activities when speed of delivery and quality are paramount.