He has 50 years of industry experience and is a leading consultant and expert in the areas of cGMP, Quality by Design, Quality Management, Regulatory Compliance & Affairs for the Pharmaceutical and Healthcare Sectors. Currently, He serves as the Quality Expert Consultant and Advisor for United Nations and is an Editorial Board Member for the Journal of Generic Medicines UK since 2015. He is also an Independent Consultant and Expert for SVKM- Shri C B Patel Research Centre Independent Ethics Committee, Mumbai, Emerson Process Management and Thermo Fisher Scientific.

Previously, He Was also the Advisor to World Bank and Regularly conducted audits & inspections in API, Finished products for regulatory bodies such as the US FDA, EU, WHO, MHRA, ANVISA, TGA, regulators in Canada, South Africa, Egypt, Japan amongst others. He previously held several established roles including the General Manager for Quality Assurance, R&D and Regulatory affairs with LykaLabs, Executive Director with  Novo Labs, Global Quality Management Positions with Pfizer and Sun Pharma and has consulted thousands of biopharma companies and scientists globally on subjects including Quality by Design Implementation, Formulations, Analytical Development, Drug Product Development, Data Integrity Compliance, Quality and Regulatory Compliance, Quality Management, CRO Monitoring, R&D, Manufacturing, Sterile Operations and Operational Excellence amongst many others.

He has delivered 461 presentations across 70 countries on areas including, QbD, PAT, US

FDA/EU Inspections, GCP/ GLP, 21 CFR part 11, Technology Transfer, Operational

Excellence, ISO, ICH, Risk Management, Regulations, Vendor development /outsourcing

etc.” He also Recently published” Covid-19 Impact & New Normal in Pharmaceutical Industry” in Journal of Generic Medicines – UK. It is also picked up by WHO on their website for benefits of Global Pharma Industry. He Was nominated as an IPA expert Geneva, for new “ICH Expert working Group-Geneva, on CTD QOS” and Served as member of IPA, IDMA, ISPE, Gujarat council of Bio-Technology etc. He Worked also as a faculty member of OPPI, IDMA, ISO workshops & was member of “GMP committee for API”by DCGI (Govt. of India).