Our trained Lead Auditors have extensive knowledge in the current regulatory requirements of API and Finished Product Manufacturers, Biotech operations, Medical Device manufacturers, Contract Manufacturers, Contract Laboratories, Suppliers and Service Providers.

We audit suppliers and CMO operations for several multinationals, including Abbott, Johnson & Johnson (Ethicon & De Puy), Merck, Amgen and Bayer.

We work with several companies to prepare for FDA and EU Competent Authority audits and can offer on-site support during the audit.


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