In addition to the services on product and process development our team also supports you with the optimization on formulation and manufacturing process either throughout the transfer of the product to one of our NextPharma sites or in the context of life cycle management including guidance on change management.

  • Scale up/adaptation of batch size to meet customers requirements
  • Evaluation of critical process parameters
  • Guidance on process validation strategy
  • Performance of process validation
  • Analytical method validation
  • Manufacturing of registration batches
  • ICH stability testing
  • Supportive stability studies (In-use stability, bulk stability…)
  • Regulatory Services