Quality and regulatory excellence for Peptides & Oligonucleotides
Ensuring global GMP compliance and regulatory support from early development through marketing authorization.
20+%
FTE working in quality & regulatory
18
Drug Master Files
9
CEPs
Excellence in quality & compliance
Official licenses and certificates
Manufacturing licenses Bachem Bubendorf
Official Swissmedic manufacturing licenses for our Bubendorf site.
Drug manufacturing licenses Bachem Americas Inc.
Official FDA drug manufacturing license for our American sites.
Manufacturing License Bachem SA (Vionnaz)
Official Swissmedic manufacturing license for our Vionnaz site.
Certificates of GMP Compliance
GMP compliance certificate of our Swiss sites.
Japanese Accreditation as Foreign Manufacturer
Official Japanese Accreditation as Foreign Manufacturer for all our sites.
ISO certificate
ISO Certificates for our St. Helens site.
Certificates of suitability (CEP)
Peptide APIs
Certificates granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) for our peptide APIs.
Small Molecule APIs
Certificates granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) for our small molecule APIs.
Your partner for global GMP compliance and regulatory support
Bachem ensures global GMP compliance and regulatory support from early development through marketing authorization.