Design and implementation of a complete supply chain solution for a small research-based biotech company


Selecting and qualifying a primary and secondary manufacturing service provider for the transfer of the in-house developed biotech drug candidate, suitable for supplying clinical-grade batches


  • Identification and qualification of suitable GMP-compliant third party manufacturing services providers and analytical services providers
  • Transfer and implementation of the in-house developed drug substance manufacturing process and controls
  • Validation of the aseptic fill of the drug product formulation

Writing of the IMPD supporting the use of these products in support of clinical trials, up to and including phase 3 trials and CMC support to regulatory affairs addressing the queries of the Competent Authorities