Regulatory support and authority inspections in all phases of the product life cycle
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.
The Pharmaceuticals Medical Devices Agency is an independent administrative agency that works with the Ministry of Health, Labour and Welfare to oversee the safety and quality of drugs and medical devices in Japan.
Current Good Manufacturing Practices govern the design, monitoring, and control of manufacturing facilities and processes and are enforced by the US FDA. Compliance with these regulations helps safeguard a drug’s identity, strength, quality, and purity.
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. The FDA is responsible for the approval of new pharmaceutical products for sale in the U.S. and performs audits at the companies participating in the manufacture of pharmaceuticals to ensure that they comply with regulations.