Director, Pharma Biotech Quality Systems

Phone: +1 202.822.1850
Country: United States

A pharma biotech professional with extensive experience in the areas of domestic and international regulations, Mehul Patel has over 17 years’ experience in the pharma biotech industry and is well versed in manufacturing and quality systems.  His areas of expertise include cGMP, CFRs, ISO, ICH regulations applicable to drug product, drug substance manufacturing and validation, and OTC drug regulations. 

Significant projects have included consent decree remediation, warning letter remediation, gap assessment, complaint investigations, supplier qualification, internal and external audit management, deviation management, data trending, change management, CMC and CTD/eCTD submissions arena.  Mr. Patel has worked as a consultant for leading pharmaceutical management consulting firms and has led several domestic and international projects, helping clients successfully remediate regulatory injunctions and notifications.