Dr. Amol
Yelgaonkar, Director, ProPharma, India
A prominent figure within the landscape of the pharmaceutical industry, Dr. Amol Yelgaonkar, Director of ProPharma, is distinguished for his in-depth knowledge, years of expertise, and deep understanding of industry trends.
Amol carries with him over 27
years of extensive experience in pharmaceutical quality assurance, quality
control, auditing, method development and validation, technology and method
transfers, medical and regulatory affairs, and operations, working for reputed
brands like Searle India Limited (a GD Searle US company), Nicholas Piramal,
Glenmark Pharma, SPI Pharma Inc., Unichem Laboratories Limited, Themis
Medicare, and Piramal Pharma. Amol is an expert in various pharmaceutical
regulations, including ICH, US FDA 21 CFR, Eudralex, and UK SI 2012
regulations. He is also an expert in remediation projects for API and
formulation manufacturing sites.
In academics, the visionary
leader completed his PhD in analytical and herbal chemistry at the University
of Mumbai after earning a master’s degree in analytical chemistry from the
renowned Savitribai Phule Pune University.
Amol is a seasoned global
executive with expertise who served as a United States Pharmacopoeia (USP)
stakeholder for Western India and South Asia from 2008 to 2014. He has
contributed to 11 monographs of the Indian Pharmacopoeia and is a life member
of the Society for Pharmaceutical Dissolution Science (SPDS). Amol is a member
of the G. N. Khalsa College’s Board of Studies in Matunga, Mumbai, as well as
the governing body of the Gahlot Institute of Pharmacy in Navi Mumbai. In
addition, he lectures as a guest at several distinguished institutions,
including the Institute of Pharmaceutical Management (IPM), GN Khalsa College,
Gahlot Institute of Pharmacy, and Vivekanand College of Pharmacy.
ProPharma and
Services
ProPharma is the leading
global, independent, single-source provider of regulatory, clinical, and
compliance services serving pharma, biotech, and medical device companies. We
have a presence on six continents, with more than 2,500 professionals providing
the highest quality of services on a global scale supported by regional
expertise. Our experts bring in a comprehensive portfolio of regulatory
sciences, clinical research solutions, life science consulting, auditing,
remediation services, R&D technology, pharmacovigilance and medical
information services to help solve complex challenges in a dynamic regulatory
environment. With our mission to improve the health and safety of patients, we
are focused on delivering the highest quality of services throughout the full
product lifecycle.
Roles and
responsibilities
Amol has an overall
responsibility for developing and growing the Quality and Compliance Consulting
services portfolio offered to existing and potential new clients in India.
Compliance and Quality services available cover, but are not limited to, the product
lifecycle from product concept through research and development, CROs, raw
material and API sourcing and validation, registration, commercialization,
manufacturing, supply chain coordination, storage, and distribution, to end
user complaint investigation, CAPA implementation, and sometimes unfortunately
batch recall from the marketplace.
Professional
Journey
Throughout his professional
journey, Amol’s diverse roles encompass General Manager, Vice President, Head
of Quality and Regulatory, and other key executive roles in different national
and international companies. His expertise encompasses most functions within
the industry, including R&D, QC, QA, BE studies, operations, supply chain,
and medical and regulatory affairs, spanning the whole product lifecycle from
APIs to finished dosage forms. Through unwavering dedication and relentless
hard work, Amol has earned a well-deserved reputation as an esteemed
specialist, with the experience of facing over 50 regulatory inspections
undertaken by various regulatory bodies like the USFDA, EDQM, MHRA, TGA, MCC,
ANVISA, EMA, etc. Amol’s impressive track record, which includes 300
inspections of R&Ds, laboratories, excipients, APIs, CROs, primary and
secondary packaging, sterilisers, supply chains, distribution hubs, warehouses,
and manufacturers of finished dosage forms in India, China, Brazil, Malaysia,
etc., firmly establishes him as an industry leader.
Areas of Expertise
Amol is a subject matter
expert in quality, compliance, and auditing services and leads the Business
Development function in the Indian Sub-Continent. He helps his clients overcome
obstacles related to quality and compliance for their export enterprises to
ensure that the goods their company produces are safe, effective, and of high
quality up until they are administered to the patient. Amol has been playing a
vital role in leading ProPharma to unparalleled milestones and laying the
groundwork for future innovation and prosperity with his visionary approach and
relentless pursuit of excellence.
Achievements
During his tenure at ProPharma,
Amol has redesigned and re-vamped the Quality Systems of various manufacturing
sites of ProPharma’s pharmaceutical clients. He has also remediated clients
from the issues arising out of failed regulatory inspections. He has got
manufacturing sites ready for regulatory inspections with his guidance in
preparing the sites much ahead of the inspections. He was successful in
obtaining regulatory re-approval for the bulk drug manufacturing site of one of
the clients. This major remediation project was delivered in a very short
duration.
Advice
He would like to mention that work should always come before pleasure. Manage your time effectively; set up a timeline for getting work completed in each of your courses or work. Don't put off until tomorrow what you can do today. At the same time, learn to strike a balance everywhere; don't be so hard on yourself that you will burn out. With all the pressure put on you by other people, it's so easy to come under that pressure, be too hard on yourself, and get frustrated if things do not work. Remember, things will fall into place if you give your best! Target to be better than yesterday; remember, going ahead and taking small steps is more important than not moving at all! He wishes you good luck to become better, to become the best!
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