Leadership
Dr. Abhay Chimankar
Founder and Director
Physician by profession and a global leader with expertise and experience more than
15 years in drug safety and pharmacovigilance regulatory affairs with additional
experience in medical writing, clinical trials, BA/BE monitoring, and auditing.
Well-versed in global regulatory guidelines and speaker at national and international
conferences. Strong manager known as a keen planner, strategist, and implementer
with solid track record of results that deliver business value through streamlined
PV operations. Audited many pharma companies as third-party auditor. Extensive experience
in USFDA and MHRA inspections, and acting as a consultant for regulatory inspections
with a good inspection outcome. One of the leading PV expert(consultant) in India.
Vision is to make Indian companies prepared for inspection with no or minimal findings.
Dr. Parag Patil
Co-founder and Director
Subject matter expert for pharmacovigilance operations with overall experience of
10 years. Strong leadership skills with extensive working knowledge on ICSR processing
(Clinical trials, Spontaneous Reports, Literature, PMS, pregnancy, etc), regulatory
reporting, E2b requirements, monitoring dedicated safety mailboxes and quality management
systems. Expertise on Argus database, gateway set up and data migration. Understanding
of EU, US, Indian requirements. Quality driven approach and have represented PV
operations in multiple regulatory and third-party inspections.