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Our Regulatory team provides compliance & regulatory support by managing documentation creation, review and submission while our Compliance group manages our Factory Compliance Programs, CMO management and facility inspections.

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Bachem also has a strong regulatory background and we are well prepared to fully support you with the required regulatory documentation such as drug master files (DMFs)

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Regulatory submissions filed by Rochem are prepared by our U.S. and Qingdao, China based Regulatory teams in coordination with product manufacturers. This ensures the most accurate and technically sound submission possible.

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CRMO can assist your company with FDA pre and post approval inspections, regulatory interpretation & submissions such as DMFs to the US FDA & EU Community, Dossiers for Certificate of Suitability of monographs of the European Pharmacopoeia, etc