Dr. Ashutosh Pudage holds a PhD in Chemistry with a specialization in pharmacokinetics and drug metabolism. With over 25 years of dynamic cross-functional experience in Pharmaceutical Drug Research and Development, his expertise spans product development, pharmacokinetics, regulated bio-analysis, and early-phase pre-clinical development.

Some of his notable achievements include successfully leading and navigating over 100 system audits from esteemed agencies such as USFDA, WHO, EU, and ANVISA. He has conceptualized, designed, and established cutting-edge bio-analytical laboratories for clinical development projects (BE/Phase I/PK). From 2014 to 2018, he headed the Business Unit at Accutest, spearheading a team of Business Managers to onboard leading pharmaceutical companies.

Dr. Pudage played a pivotal role in advancing lead NCEs for COPD and Diabetes during his tenure at Glenmark R&D. He is adept at setting up robust systems to meet and exceed regulatory requirements, ensuring compliance and quality assurance. Additionally, he has presented and defended project-specific case studies to secure authorizations in numerous meetings with regulatory agencies for clients.