Vetter supports you through all phases of regulatory submission. We have an excellent track record with global regulatory agencies, including the FDA, EMA, and PMDA (Japan), and we currently manufacture approximately 50 customer products (drug products and diluents) with FDA approval.
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 of all kind of documents
In addition, Vetter has a lot of experience with 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. This includes routine cGMP and pre-approval inspections either on-site or paper-based.