From Concept to Approval

Servier offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

Within our manufacturing plants, we gather both technical R&D and manufacturing services to optimize collaborative synergies and ensure high quality, reduced costs and reduced time to market. Our labs and workshops have state-of-the-art equipment and are staffed with highly trained teams to manufacture clinical batches according to GMP requirements. They are dedicated to chemical, analytical and formulation development as well as process development and product robustness. In close collaboration with these teams, our Regulatory Affairs experts make sure you can gain the scientific data required for regulatory submissions and support you in CMC chapters elaboration for investigational files (IMPD, IND) and MA dossiers (CTD, NDA).

Clinical Supply Capabilities

  • Regulatory CMC
  • Process development and validation
  • Analytical development and validation
  • Microbiology development and validation
  • ICH stability testing
  • Clinical batch manufacturing
  • Packaging of clinical trial material
  • Product transfers

Process & Analytical Development

  • API Synthesis
  • Formulation development
  • Physical and chemical characterization
  • Process, analytical and microbiology development and validation
  • Impurity tracking and characterization
  • In-process production support
  • High-quality analytical data

GMP Clinical Batch Manufacturing

  • Scale-up studies
  • Packaging into mixed blisters or bottles
  • Randomization management
  • Comparator sourcing
  • Worldwide distribution