Mohamed Ghorab, PhD

Mohamed Ghorab, PhD

Mohamed Ghorab, PhD

Principal Consultant

Mohamed has nine years U.S. FDA/CDER experience in CMC risk-based review of ANDAs and in the development of policies related to the quality of drug products (NDAs and ANDAs), biologics, and biosimilars (BLAs), and drug-device combination products. He also has seven years of formulation and process development experience in the pharmaceutical industry. He was an FDA liaison to the 2015-2020 USP Excipients Expert Committee, promoting the FDA/CDER position on developing new standards and/or revising existing standards in excipients monographs.

Work experience

Mohamed expertise includes formulation and process development for oral, topical, and injectable drug products. He has experience in the development of policies related to drugs and biologics (such as guidances and regulations). He has extensive knowledge of USP standards, ICH Guidelines, and FDA regulations for drugs and biologics (21 CFR 314 and 600s), including CGMP regulations (21 CFR 210, 211, and 212).

Prior to joining Parexel, Mohamed was an acting Director for the Division of Regulations, Guidance and Standards in CDER/OPQ/Office of Policy for Pharmaceutical Quality (OPQ) at the FDA.  

Education

Mohamed received his Ph.D. in Pharmaceutical Sciences from Duquesne University, PA and his B.S in Pharmacy from Cairo University, Egypt.

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