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Pharma Synthesis
Early phase services - synthesis of clinical batches

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.

The Development Services for Active Pharmaceutical Ingredients include:
  • Chemical process development
  • GMP manufacture of clinical trial materials
  • Analytical methods development and validation
  • New commercial route scouting
  • Polymorphism assessment
  • ICH stability studies

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
  • 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

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