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DPT Adds Regulatory Prep Service

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By: Tim Wright

Editor-in-Chief, Contract Pharma

DPT Laboratories has added preparation of the chemistry, manufacturing and controls documents (CMC) in the Common Technical Documents (CTD) format as an optional service for customers applying for approval of new drugs. The new service provides preparation of CMC modules 2 and 3 documentation throughout formulation and process development in the common format established by the International Commission on Harmonization for submitting NDAs to the FDA and regulatory agencies in the EU and Japan...

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