When developing new pharmaceutical products, it is very important to get to the Phase I clinical trial in a fast, efficient and cost-effective way. With its oral solid dose Quick-to-Clinic™ program, Thermo Fisher Scientific can deliver a prospective drug in a phase-appropriate formulation for first-in-human studies in as little as 14 weeks from API receipt to release to clinic.
This process includes one-months stability testing data, to help complete regulatory submissions. The Milton Park facility provides services for drug product formulation, analytical and clinical batch manufacturing and will integrate with the Horsham facility to provide clinical services for labelling, packaging and distribution.
For more information on the Quick-to-Clinic™ program, download the brochure.
To learn how Reneo Pharma was able to get to clinic in 14 weeks from delivery of their API, watch the video.
SOURCE: Thermo Fisher Scientific