Leveraging our scale-up solutions will give you access to a risk assessment and proven acceptable range (PAR) studies, as well as validation of analytical methods and the manufacturing process. If needed, our QA/regulatory compliance team can provide data and support for the CMC portion of your submission. API for use in clinical trials are produced at state-of-the-art manufacturing facilities in Europe and North America. All our facilities comply with cGMP regulations and are regularly inspected by national regulatory agencies.
A team of experts will surround your discovery with a full range of technologies and analytical services to run the project with the highest degree of flexibility and deliver on-time, with exceptional yields and superior quality. In late-stage trials and beyond, your drug substance will be manufactured at a cGMP commercial production facility, where a team of experts continuously work to:
Learn more about our early development, late-phase and commercial oral solid dose solutions