Bioequivalence / Bio Analytical Auditor

  • • Our Auditor comes with comprehensive experience of 20 years specializing in Clinical trials (Phase-I to IV), Bioavailability & Bioequivalence Studies, Documentation Procedures and Quality Systems.

  • • Has audited all the major CROs in India for their systems and processes for efficiency and compliance.

  • • Has provided Regulatory Support through alliance partners for getting BE-NOC, T-License etc. from the State Regulatory bodies.

  • • Has hosted inspections of various regulatory agencies (US-FDA, affsaps, ANVISA, AGES-Austria) of the facility and the scientific data leading to no major observations or findings.

  • • Has implemented quality systems as per USFDA cGLP, cGMP guidelines and have conducted quality system audits for a multinational clinical research giant

  • • Formerly Head for clinical research operations and has led and mentored a team of over 60 individuals across diverse verticals- Bioanalytical, PK & Statistical, Clinical Operations, Medical Writing, and Regulatory affairs.

  • • Was also the Head of Bioanalytical and Pharmacokinetic Operations where in which his key responsibilities included as that of a Study Director for all the assigned clinical trials done In-house, giving PK inputs for all the study protocols, and reviewing PK and statistical analysis for its authenticity and accuracy.

  • • Prior to his work as the Head of operations she was appointed as Senior Research Scientist for Clinical Pharmacology and Pharmacokinetics where in which she conducted around 100 pilot and pivotal bio-availability and bio-equivalence studies for various immediate release, delayed release and extended release formulations as per approved protocols to assess their pharmacokinetic behaviour.

  • • Has authored many international publications on drug development.

  • Our Auditor comes with comprehensive experience of 20 years specializing in Clinical trials (Phase-I to IV), Bioavailability & Bioequivalence Studies, Documentation Procedures and Quality Systems.

  • Has audited all the major CROs in India for their systems and processes for efficiency and compliance.

  • Has provided Regulatory Support through alliance partners for getting BE-NOC, T-License etc. from the State Regulatory bodies.

  • Has hosted inspections of various regulatory agencies (US-FDA, affsaps, ANVISA, AGES-Austria) of the facility and the scientific data leading to no major observations or findings.

  • Has implemented quality systems as per USFDA cGLP, cGMP guidelines and have conducted quality system audits for a multinational clinical research giant

  • Formerly Head for clinical research operations and has led and mentored a team of over 60 individuals across diverse verticals- Bioanalytical, PK & Statistical, Clinical Operations, Medical Writing, and Regulatory affairs.

  • Was also the Head of Bioanalytical and Pharmacokinetic Operations where in which his key responsibilities included as that of a Study Director for all the assigned clinical trials done In-house, giving PK inputs for all the study protocols, and reviewing PK and statistical analysis for its authenticity and accuracy.

  • Prior to his work as the Head of operations she was appointed as Senior Research Scientist for Clinical Pharmacology and Pharmacokinetics where in which she conducted around 100 pilot and pivotal bio-availability and bio-equivalence studies for various immediate release, delayed release and extended release formulations as per approved protocols to assess their pharmacokinetic behaviour.

  • Has authored many international publications on drug development.

  • For System Demo and further information, please call +91 98100 68241 or mail us at bd@crqa.in