Our clients’ early phase manufacturing needs are conducted from the UK and then scaled up when required at our sites in the US and India.
We provide MHRA licensed facilities for GMP synthesis services and the manufacturing of small scale APIs. While programmes for phase I/II are supported from the UK, phase II-launch programmes are supported from our pilot plant and commercial sites in the US and India. As we manage the scale-up process internally, this means that we can provide a smooth and flexible API manufacturing process to all of our clients, from small to large scale.
Our smaller scale projects involve the rapid movement from non-GMP to GMP synthesis. Things won’t always go according 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 for API synthesis services that will help you overcome any teething problems, get in touch today.
Our services include:
- GMP synthesis
- Manufacturing small scale APIs
- Analytical validation
- QA release
- Stability studies
- CMC writing
- CMC support
All of our services are delivered to European, US and Japanese regulatory standards and we have a track record of delivering compliant materials for clinical trials. In fact, we have delivered over 75 individual APIs produced to GMP at a small scale for clinical trials over the last 10 years.
As part of our GMP synthesis services, our UK site is equipped with several GMP kilo laboratories, all class 100,000 standard and a variety of vessel sizes of up to 50 litres.
At our US site, we have pilot plant facilities including 4 suites containing glass lined steel reactors, ranging from 250 L – 10,000 L.