Drug Substance Development & Production for Emerging Pharmaceutical Companies

PCAS has more than 15 years experience in providing full CMC services for small molecule development and cGMP manufacture to start-up companies.

Customers will have access to appropriate kilo-lab and pilot capabilities for NCEs through a network of 5 FDA inspected sites

• Aramon (France)
  R&D labs - kilo lab - pilot unit - commercial scale

• Limay (France)
  R&D labs - pilot unit - commercial scale

• Villeneuve-la-Garenne (France)
  Pilot - Small scale API facility - commercial scale

• Turku (Finland)
  R&D labs - kilo lab - commercial scale

• Santa-Rosa (California, USA)
  R&D labs - cGMP Kilo-lab production

More than 100 chemists are involved within PCAS with process development and scale-up activities using strong chemical expertise in conventional organic synthesis and proprietary biocatalysis technology.

Additional strengths provided for SUCCESSFUL FILING are:

• In-house Regulatory Affairs team for IND / IMPD (more than 60 active DMFs)
• A total of 30 Quality Assurance staff
• Integration of early intermediates for secure supply from 3 ISO 9001 chemical plants
• Strong environmental concern in process development and production.

Customer will also benefit from professional PROJECT MANAGEMENT

• Dedicated project manager
• Open communication with our technical experts
• Regular reporting
• Absolute respect of customers background and generated IP
• Confidentiality