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).

Process Development

• Our specialized R&D teams offer customized solutions
• The entire product development process is fully supported, from the development of your API synthesis, the development of formulation concepts, the manufacturing and packaging of clinical trial material, through to the full compilation of regulatory files

Manufacturing

• Scale-up studies
• Clinical batches manufacturing
• Packaging of clinical trial material (mixed blisters / 
  bottles / randomization management / comparator sourcing / worldwide distribution)
• Product transfers

Analytical

• Physical and chemical characterization
• Process development and validation
• Analytical development and validation
• Microbiology development and validation
• Impurity tracking and characterization
• In-process production support
• ICH stability testing
• Analytical data for high-quality products, processes and business decisions