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Quality Assurance
For cGMP-compliant production of biological active pharmaceutical ingredients, we set ourselves the highest standards with our pharmaceutical quality assurance system. Our quality management system is based on applicable local and international guidelines of FDA, EMA, ICH or WHO. Our sites have been approved by the FDA, EMA, ANVISA, MFDS (Korea), PMDA (Japan) and others for commercial manufacturing of different products.
Through our extensive quality assurance network, we manage all quality-relevant aspects including preparation of the necessary documents steering all aspects of manufacturing processes and process validation. Moreover, we put particular emphasis on regular and careful training of our employees, because only thoroughly implemented processes ensure the necessary quality of your products.
Our quality systems and compliance with cGMP requirements is verified by frequent authority inspections and client audits.
Over the years, Wacker Biotech has successfully supported its customers filing INDs, IMPDs, DMFs, MAAs and BLAs. Upon request, Wacker Biotech will draft CMC-related sections of your dossier/application. Wacker Biotech has a strong track record of supporting customers in manufacturing of clinical trial material and approved products.
Our services include:
- Quality system inspected by FDA, EMA, ANVISA (Brazil), MFDS (Korea), PMDA (Japan) and others
- GMP and manufacturing licenses according to applicable local law
- Release of batches by Qualified Person (QP)
- 30+ years of commercial bioproduction without critical or major findings by authorities
- Quality support through the whole lifecycle of your product
- Review and support of writing of the CMC-related sections of your dossier or application