Trusted Global Quality & Compliance

Quality and regulatory excellence for Peptides & Oligonucleotides

Ensuring global GMP compliance and regulatory support from early development through marketing authorization.

Hero_subpage_img
Pattern
Pattern

20+%

FTE working in quality & regulatory

18

Drug Master Files

9

CEPs

image_text_img

Excellence in quality & compliance

With decades of global GMP experience and an integrated regulatory and quality organization, we provide the confidence of proven compliance and seamless support from early development through approval. Our strong record with Swiss, EU, US, and Japanese authorities reflects our commitment to excellence, while our world‑class quality infrastructure -driven by dedicated QA, QC, and regulatory experts - ensures rigorous analytics, impurity profiling, stability studies, and reliable reference standards that safeguard product integrity end to end.
Pattern

Official licenses and certificates

Drug manufacturing licenses Bachem Americas Inc.

PDF

Official FDA drug manufacturing license for our American sites.

Manufacturing License Bachem SA (Vionnaz)

PDF

Official Swissmedic manufacturing license for our Vionnaz site.

Certificates of GMP Compliance

PDF

GMP compliance certificate of our Swiss sites.

Japanese Accreditation as Foreign Manufacturer

PDF

Official Japanese Accreditation as Foreign Manufacturer for all our sites.

ISO certificate

PDF

ISO Certificates for our St. Helens site.

Certificates of suitability (CEP)

Peptide APIs

PDF

Certificates granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) for our peptide APIs.

Small Molecule APIs

PDF

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.