Gaurang Bhavsar, Associate Director of Regulatory Affairs at Micro Labs USA, Inc., brings over 20 years of experience and a Master\u2019s in Industrial Pharmacy. He leads FDA-aligned strategies and remains dedicated to advancing regulatory science, product development, and patient safety.<\/p>\n\n\n\n
I hold a Master of Science in Industrial Pharmacy and have over two decades of experience in regulatory affairs within the pharmaceutical industry. Currently, I serve as the Associate Director of Regulatory Affairs at Micro Labs USA, Inc., where I lead important regulatory and compliance strategies to ensure everything aligns with FDA standards throughout the product lifecycle.<\/p>\n\n\n\n
I\u2019m proud to hold the Regulatory Affairs Certification (RAC), which shows my expertise in regulatory processes. I\u2019ve been recognized as a “RegEx Pro,” \u201cRAPS Platinum Most Valuable Contributor,\u201d and “RAPS Mentor” by the Regulatory Affairs Professional Society (RAPS) for sharing my knowledge. The American Association of Pharmaceutical Scientists (AAPS) also named me a \u201cSilver Contributor\u201d for my leadership in pharmaceutical and regulatory science.<\/p>\n\n\n\n
My research interests include Regulatory Compliance, Regulatory Requirements, DSCSA, Validation, Nitrosamine Impurities, Microdialysis, Anti-fungal Activity, Product Development, and Patient Safety\u2014areas where I\u2019ve made significant contributions to the pharmaceutical industry. I\u2019ve also helped shape industry standards by serving as a panelist on DSCSA compliance alongside wholesalers and dispensers.<\/p>\n\n\n\n
Through my leadership and dedication, I continue to drive progress in regulatory science, product development, and patient safety, working to establish myself as a thought leader in the pharmaceutical industry.<\/p>\n\n\n\n
I come from a family that believes in public service and has always been engaged with various organizations to support the community. The pharmaceutical industry produces medicines, which are key products that we need throughout our lives\u2014from birth until death. I chose to pursue a Bachelor of Pharmacy after high school in India, and through a campus interview, I got my first professional break in the Regulatory Affairs department.<\/p>\n\n\n\n
Although I worked there for only six months, I learned a lot and made the determination that regulatory affairs should be my primary career focus. Later, I realized that a bachelor\u2019s degree was not enough to fulfill my dream job, so I decided to move to the USA to pursue a master\u2019s degree in industrial pharmacy.<\/p>\n\n\n\n
Q3. Tell us more about your business\/company, your job profile, and the specific responsibilities you undertake.<\/strong><\/p>\n\n\n\n Micro Labs USA, Inc. is a wholly owned subsidiary of Micro Labs Limited, India, which is one of the top twenty pharmaceutical companies in India and was founded in 1973. The US headquarters markets high-quality, affordable generic medicines trusted by patients and healthcare professionals. As our motto states, it is Micro Labs\u2019 attention to \u201chealth in the small details\u201d that allows us to provide best-in-class service and supply to our customers. These products are made in three state-of-the-art USFDA-approved facilities \u2013 one in Goa and two in Bangalore, India \u2013 focusing on oral solid tablets and capsules, injections, ophthalmic, and oral solutions.<\/p>\n\n\n\n I have been working as Associate Director \u2013 Regulatory Affairs since May 2019.<\/p>\n\n\n\n My key responsibilities include:<\/p>\n\n\n\n \u2013 Acting as the US Regulatory and Compliance leader, responsible for developing, implementing, and maintaining regulatory strategies throughout the product lifecycle. DSCSA (Drug Supply Chain Security Act) compliance for pharmaceutical manufacturers<\/a><\/p>\n\n\n\n
\u2013 Managing generic product (ANDA) submission documents and communications with the FDA and Micro Labs Limited, India, for product development and approval.
\u2013 Sharing regulatory intelligence with stakeholders to assess impacts on products and adapt to regulatory changes to prevent business disruption.
\u2013 Collaborating with the Associate Vice President and managers to ensure compliance and project completion, offering strategic regulatory advice to speed market approval.
\u2013 Reviewing all generic product submissions, including original submissions, PAS, CBE-0, CBE-30, post-marketing requirements, annual reports, and REMS, and maintaining all related communications.
\u2013 Managing Certificate of Pharmaceutical Product (CPP) submissions to the FDA for marketing approval in Rest of the World (ROW) markets.
\u2013 Planning and implementing PLAIR and launch activities for smooth US market distribution.
\u2013 Managing all state licenses for US distribution and advising on compliance with state-specific regulations.
\u2013 Overseeing Drug Price Transparency reporting and Drug Take Back programs.
\u2013 Reviewing drug listings and SPL-related activities for approved products and ANDA applications, ensuring labeling compliance.
\u2013 Monitoring and addressing product quality and safety complaints through pharmacovigilance systems.
\u2013 Managing field alerts, product recalls, and drug notifications in accordance with the Drug Quality and Security Act (DQSA) and FDA requirements.
\u2013 Overseeing ATP (Authorized Trading Partner) EPCIS connections for seamless data exchange and exception handling under DQSA.
\u2013 Executing and managing Quality and Pharmacovigilance Agreements with contract manufacturing organizations (CMOs).
\u2013 Performing quality audits with vendors, distribution centers, return processors, CMOs, and other service providers in the US.<\/p>\n\n\n\n