Drug Substance development for emerging and large pharma companies
PCAS has more than 20 years of experience in providing full CMC (
PCAS would be delighted to discuss your custom synthesis needs for clinical materials - either APIs or Regulatory Starting Materials (RSMs). Our expertise is focused on rapid and cost effective development while integrating the most powerful technologies, such as engineered enzymes and methodologies such as Quality by Design (QbD).
Our customers will have access to a network of 3 R&D centers, 5 pilot units and 4 GMP API sites to ensure a smooth scale-up from phase I/II to the commercial stage. PCAS also offers the option of back-integration on critical raw materials in three ISO-9001 chemical sites in Europe or Canada.
The development services include:
- chemical process development,
- analytical method development and validation,
- GMP manufacture of clinical trial materials,
- Production of registration and validation batches
- polymorphism assessment,
- ICH stability studies,
- A dedicated team of experts will be appointed to follow your project and guarantee on-time completion, meeting specifications and budget constraints.