We provide MHRA and FDA licensed facilities for synthesis services, including GMP synthesis and production of APIs to current Good Manufacturing Practice (cGMP). While programs for phase I/II are supported from UK, phase II-Launch programs are supported from India.
UK-based projects tend to be smaller scale but involve the rapid movement from non-GMP to GMP. Things won’t always go to plan at this stage but it’s how you deal with these issues that matter. So, if you’re after a nimble and flexible partner that will help you overcome any teething problems, reduce your timelines and maximise efficiency, then get in touch today.
Our services include GMP synthesis / API manufacture and release and process validation. All are delivered to European, US and Japanese standards and we have a proven record of reliably delivering clinical material production (over 60 individual APIs produced for clinical trials).
At our UK site, we are equipped with several GMP kilo laboratories including a class 100,000 clean room and a variety of vessel sizes up to 100 litres. At our India sites, we are equipped with GMP Kilo laboratories with equipment up to 65 litre reactors. Pilot plants with over 60 reactors from 100 – 1000 L are available and are equipped with molecular sieves, cryogenic conditions etc. We also have an independent quality assurance department and provide analytical support to all client projects.