Merits

  • Handled > 350 Bioequivalence studies for various regulatory agencies such as USFDA, EMA, MHRA, Health Canada, WHO, CDSCO, TGA, MCC, GCC & SFDA.
  • Both CRO & Pharma company experience helps to successful completion of the Bioequivalence study and addition to ensuring the right sample size, sampling points, BE budget management.
  • Expertise in Pharmacokinetic analysis and handling PK & statistical software.
  • Author of the book, “Are you going to buying medicines” published in the year of 2011.
  • Article publishment - “Bioequivalence Guidelines Requirements for Orally Administered Generics (IR Products) in Gulf Cooperation Council Countries, European Union and United States of America” Elambharathy Elangovan*Department of Bioequivalence, Research & Development, Jamjoom Pharmaceuticals, P.O. Box # 6267, Jeddah-21442, Kingdom of Saudi Arabia, was published in the Journal of Bioequivalence and Bioavailability.