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Regulatory Affairs    
 

Bachem is # 1 in peptides. Bachem has been profitable for almost 40 years. Bachem has the financial resources to meet growing regulatory and cGMP demands. Bachem does not need short time profit at the expense of compliance.

cGMP peptides are our core business. Bachem will do whatever is necessary to comply with cGMP regulations.

  • Bachem's revenues are approximately 182 million Swiss Francs (2009), of which approximately 150 million Swiss Francs come from Active Pharmaceutical Ingredients (APIs). For more details see our annual report.

  • Bachem knows what's needed for regulatory success. Bachem has the expertise and resources to file registration documents on time. Bachem has 65 national EDMF approvals, 35 active US-DMFs, several active DMFs in other countries and submitted many technical packages in support of successful IMPD and IND applications.

  • Bachem's RA staff consists of 10 well experienced people holding university degrees in science.

  • Together with peptides, Bachem offers a wide range of services, i.e. indicative stability studies, ICH stability studies, analytical validation, reference standards, analysis of finished dosage forms etc.

  • Bachem supplies cGMP grade products to the majority of Big Pharma. 20 of the 25 largest pharmaceutical companies worldwide rely on our cGMP system.

  • Bachem is continually benchmarking cGMP standards with major pharmaceutical companies, and Bachem is always ready to be inspected. In 2002 customers conducted formal QA audits for a total of 50 days.

For more details concerning the cGMP production sites in Europe and the USA please click here.