Most of our team has worked in the Pharma or CRO industry and have expertise in auditing/monitoring of clinical/bioanalytical aspects of bioequivalence studies.

Has over 20 yrs of diverse experience in pharmaceutical and CRO industry specializing in Bioequivalence Studies, Formulation and Analytical development, Documentation Procedures and Quality Systems. Has extensive in-depth technical, clinical/bioanalytical and regulatory experience and knowledge of PK and bioanalysis.

Was instrumental in setting-up a full- service CRO and have executed more than 1000 bioavailability and bioequivalence studies for all major regulatory region – USFDA, UK-MHRA, EMEA, ANVISA, TGA-AUSTRALIA, TPD-Canada, MCC-South Africa etc. Successfully faced numerous audits and inspections from US-FDA, ANVISA, affsaps-FRANCE, AGES-Austria, DCGI etc.