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Commercial Manufacturing

Regulatory support

Support throughout your product life cycle 

Vetter supports you through all phases of regulatory submission. Currently manufacturing approximately 50 FDA-approved products, we have a solid success record with global regulatory agencies, including the FDA, EMA, and PMDA (Japan).

Our CMC (Chemistry, Manufacturing, Control), cGMP (Current Good Manufacturing Practice), and QA (Quality Assurance) experts will support you with:
  • Annual Product Reviews (APRs) and Product Quality Reviews (PQRs)
  • Post-approval variation filing
  • Authority requests for additional documentation
 

National and internal authority inspections

Our facilities undergo more than 10 authority inspections per year. Over the past decade, we’ve passed inspections by nearly every regulatory body around the globe, including either on-site or paper-based routine cGMP and pre-approval inspections.