Quality Management

Wacker Biotech works in accordance with pharmaceutical GMP (Good Manufacturing Practice) to ensure the high quality required for the approval of clinical studies or market approval by the American FDA (Food and Drug Administration) or the European EMA (European Medicines Agency). The production facilities at all three company sites are FDA and EMA certified.
Quality Assurance / Regulatory Affairs
Wacker Biotech holds biomanufacturing certificates from the relevant authorities for all sites, and follows the ICH Q7 guidelines for GMP-compliant production of active pharmaceutical ingredients (APIs) and Drug Product (DP). All three GMP production facilities are approved for commercial manufacturing by EMA, U.S. FDA and/ or ANVISA.
With more than 1,100 released batches Wacker Biotech has a strong track record in supporting clients over the years with manufacturing of clinical trial material and approved products. Over the years, Wacker Biotech has successfully supported its customers in filing of INDs, IMPDs, DMFs, MAAs and BLAs. Upon request, Wacker Biotech will draft CMC related sections of your dossier/application.