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Repeat Solutions Circle
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Mohamed K. Ghorab

Vice President, Technical PC, Regulatory Strategy
Parexel

Mohamed Ghorab, Ph.D. is a Vice President, Technical PC, Regulatory Strategy at Parexel International providing CMC regulatory advice to clients from the Biotech and Pharmaceutical Industry on the preparation of regulatory submissions (such as INDs, NDAs, ANDAs and BLAs) and interactions with regulatory authorities. Prior to joining Parexel, he was a Branch Chief and later acting Director for the Division of Regulations, Guidance and Standards in CDER/OPQ/Office of Policy for Pharmaceutical Quality (OPPQ) where he gained extensive regulatory experience in the development of policies (regulations and guidances) and resolving complex regulatory challenges related to quality of drug products including biologics. Mohamed had also worked at the FDA as a chemistry reviewer assessing the CMC sections of ANDAs for generic drug products and was an FDA liaison to the 2015-2020 USP Excipients Expert Committee promoting FDA/CDER position on the development of new standards and/or the revision of existing standards in excipients monographs. His expertise from working at the FDA and in the pharmaceutical industry, includes formulation and process development for oral, topical and injectable drug products.

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