QA R&D product related

  • IMP manufacturer’s and clinical supply QP batch release
  • Development and validation of analytical methods
  • Analytical and Technology transfers
  • Quality by Design
  • Scale-ups
  • Manufacturing Process Validation and Qualification
  • Establishing of stability programs and shelf life claims
  • Preparation to FDA PAIs including support during inspections

Please note that PMC has comprehensive experience in the development and registration of (complex) injectable generics.