Dr. Amol Yelgaonkar - A Visionary Professional Leading Pharmaceutical Quality and Compliance with Expertise

 

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!