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Regulatory Affairs Services - Partnering for Success

Explore how you can benefit from a comprehensive service portfolio when you partner with Bachem Americas Regulatory Affairs (RA). By paving the way through all critical milestones, our regulatory team is committed to achieving a successful outcome for you. From early development to submission and beyond, we can help you along the way. Some of the services we offer include: -Chemistry, Manufacturing and Controls (CMC) packages early in the development cycle to support INDs or CTAs -extensive experience in authoring and submitting Drug Master Files (DMFs)/ BMF/ASMF and CEP since 1979 to support NDAs, ANDAs, MAAs. By choosing Bachem as your partner, you will have access to a team of regulatory experts with over 50 years of combined experience and a proven track record in regulatory submissions. Featuring Fariba Jashnian, Vice President, Central Function Quality, Quality Assurance CFQ, Bachem Contact the experts today: https://www.bachem.com/contact/ --------------------------------------------------------------------------------------------------------------------------- About Bachem: Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company, which has over 50 years of experience and expertise, provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. Learn more about our products and services at https://bit.ly/3LykCeY