Compliance oversight of the process development and validation of a Biosimilar active ingredient manufacturing at a CMO on behalf of the sponsor biopharmaceutical company


Providing GMP compliance oversight to the process scaling-up and validation of a complex biosimilar manufacturing by a qualified contract manufacturing organization, up to Marketing Authorization Application filing, responses to the queries from the Competent Authorities and final successful registration


  • Comprehensive process characterization
  • Ancillary activities including equipment qualifications and cleaning validations
  • Successful completion of the process validation runs
  • Assessment and management of all process-related and non process-related deviations and changes over the course of the PPQ runs
  • Compliance strategy determination towards successful filing of the process validation package