Ashish Mungantiwar's Biography
Ashish Mungantiwar, Executive President – Medical Services, Macleods Pharmaceuticals Limited, India
Dr. Ashish Mungantiwar is currently working as Executive President in R and D in Macleods Pharmaceuticals Limited, Mumbai. He is heading Bioequivalence, Pathology, Clinical Trials and Pharmacovigilance. He has rich experience of more than 20years in Pharmaceuticals industry. Dr. Ashish completed his PhD in Pharmacology from Mumbai.
He served as Study Director for more than 3000 Bioequivalence studies. Conducted studies on orals, inhaler, in vitro phosphate/Bile acid binding studies, Vasoconstriction studies on topical steroids, IVRT/ IVPT studies on topicals.
He has successfully handled more than 40 regulatory inspections from USFDA, WHO, UKMHRA, DCGI, ANVISA , Malaysia and Thailand. As Head of Pharmacovigilance, he ensures Benefit risk management of all Macleods pharmaceuticals drugs throughout their life cycle and ensures all required Pharmacovigilance obligations as per PvPI, US FDA and MHRA. He has successfully faced USFDA Inspection on Pharmacovigilance.
As Head of Clinical trials, he has completed more than 100 clinical trials in phase III and phase IV in various therapeutic segments for different regulatory authorities like DCGI, WHO and US FDA
He has been invited as speaker in various international and national conferences. As Laboratory Director of Pathology, he has successfully faced inspections from NABL several times.
He plays pivotal role in identifying new products for domestic market and leads the team of formulation development for domestic market. He has obtained more than 20 new drug approval from DCGI as first time launch in Indian market and is actively presenting the cases to Subject Expert Committee of DCGI. He has more than 30 publications in international and national journal. Dr.Ashish holds two patents on his name and five patent are under pending for grant. He has also written chapter in book of Scientific basis of Ayurvedic Therapy CRC Press Washington. Dr. Ashish is guide for PhD students. Four students successfully completed PhD under his guidance and currently 3 students are pursuing.