30+ years in the industry, 24+ years with Eli Lilly. Extensive experience in Global Quality Auditing with over 100 sites audited globally in 16 different countries; covering multiple regulations & products: Parenterals, Orals, Topical, API; PAI readiness and Commercial Manufacturing; Human & Animal Health.
Raj has led Quality teams at Lilly's Parenteral Manufacturing Sites in Indianapolis,USA. He also led the CMO manufacturing-Quality activities for Lilly and set up the Supply Chain Team from scratch to outsource Lilly manufacturing in India.
Raj is passionate about leveraging technology to improve compliance and quality in the pharmaceutical industry.
Raj holds three Master's degrees: In Regulatory Quality Assurance from Purdue University, (2) In Business Administration from IIM-Bangalore, and (3) Pharmaceutical Sciences from University of Delhi. He is also a Certified Quality Auditor (CQA) from ASQ, Six Sigma Black Belt, Regulatory Affairs Certification (RAC) and a member of PDA.
Mohit Gupta brings over 35 years of leadership in pharmaceutical development, GMP compliance, and regulatory strategy. He has held senior roles at B. Braun, Teva (Allergan/Actavis/Watson), Caraco (Sun Pharma), and Ranbaxy (an Eli Lilly JV), and currently leads Gurukul Pharmaceutical Consultants LLC, where he advises on CMC submissions, technology transfers, validation, and compliance remediation.
He has directed global technical teams through 14 FDA inspections with zero 483 observations and has overhauled quality systems for contract manufacturers to meet FDA and EMA standards. His work includes developing sustainable quality frameworks, drafting SOPs, training teams, and resolving 483 and Warning Letter issues. Mohit also serves as an expert witness in federal litigation involving regulatory compliance, impurities, and recalls.
He holds advanced degrees in Pharmaceutics and Business Administration, is a Six Sigma Green Belt, and maintains Regulatory Affairs Certification (RAPS) in pharmaceuticals and medical devices.
Brent is a seasoned leader in Regulatory Compliance, Quality Assurance, and Regulatory Affairs, with a distinguished career spanning 38+ years with the FDA and global pharmaceutical companies including Pfizer, Johnson & Johnson, and Eli Lilly. His expertise bridges technical depth and strategic oversight across GxP domains—from early formulation development to post-market surveillance.
With decades of hands-on experience, Brent has led the design and deployment of global quality management systems for both development (GLP/GCP) and commercial (GMP) operations. Extensive interaction experience with FDA and other international authorities. He has supported numerous international manufacturing sites in preparing for inspections by the FDA, EMA, and other national authorities, earning a reputation for inspection readiness and regulatory alignment.
In 2024, Brent founded Qualitas Pharma Consulting LLC, a firm dedicated to delivering scalable, regulator-aligned solutions in gap assessments, GxP compliance, and global quality systems to pharmaceutical clients.
Rajkumari holds a Ph.D in Pharmacology and is a Registered Pharmacist. She has a long pharmaceutical industry experience in USA and India for over 30 years including pharmacy operations, teaching pharmacology at reputed institutes and bioequivalence studies on the clinical side.
With a keen eye on details, she manages a multitude of operational activities at Regunalys to bring our ever increasing portfolio of analytics tools together, exhibit and market them including back-end customer support activities.
Sudhir Gambhir is a Pharmacy graduate and a Postgraduate in Law from premier Indian universities. With extensive experience in the pharmaceutical industry, he has worked in diverse roles spanning marketing, training, and product development with leading global MNCs.
A Registered Patent Agent, Sudhir now practices law with a strong focus on intellectual property rights. He advises and represents domestic as well as international clients in securing and protecting their patents, trademarks, copyrights, and industrial designs across multiple jurisdictions, including India.
As a founding partner of Gambhir & Associates, Sudhir also handles complex disputes involving infringement and passing off of IPRs, along with civil litigation, recovery suits, and related legal matters. His unique blend of pharmaceutical expertise and legal acumen makes him a trusted advisor at the intersection of healthcare, innovation, and law.
A business specialist with strong strategic, marketing, distribution and processes skills honed over 30 years of rich experience, Rahul has led several Multinational brands in India. Amongst his longest stints is Johnson & Johnson where he had leadership roles in various departments (production, quality, distribution, marketing, management).
He brings valuable insights into the industry, giving him an edge in his role of marketing Regunalys to the pharma industry.
If you have questions or clarifications that we can help with, please reach us at: raj.gulati@regunalys.com
