Regulatory Affairs

Bachem has close to 50 years of experience in the cGMP production of peptides and complex organic molecules. We have the size and financial resources to meet the ever growing regulatory and cGMP demands.

The manufacturing of peptide and complex organic molecule APIs is our core business; compliance to cGMP regulations and to the corresponding guidelines is thus key to our success.

• Bachem has gained the required expertise from a multitude of successful registrations all over the world: Bachem has 65 national EDMF approvals, 35 active US-DMFs, 10 CEPs, and several active DMFs in many other countries. We have submitted many technical packages in support of successful IMPD and IND applications.
• More than 20% of the Bachem workforce is engaged in quality assurance, quality control and regulatory affairs. Hence, we guarantee comprehensive quality services and support in all phases of a drug’s life cycle.
• Together with peptides and complex organic molecules, Bachem offers a wide range of services including indicative stability studies, ICH stability studies, development of validation of analytical methods, and establishing reference standards.
• Bachem supplies cGMP grade products to the majority of Big Pharma. Of the worldwide pharmaceutical companies, 20 of the 25 largest rely on our cGMP system.
• Bachem is continually benchmarking cGMP standards with major pharmaceutical companies in more than 50 days of formal customer QA audits per year and is therefore always ready to be inspected.

More details on our cGMP production sites in Europe and the USA