Meet Our Experts: Team Member Profiles
Mr. Anil Chaudhari, M.Sc. Microbiology
Founder and CEO, Operon Strategist | Medical Device Regulatory and Turnkey Project Consultant
With over 25+ years of experience in Regulatory Affairs and Quality Assurance within the Medical Device and Pharmaceutical industries, Mr. Anil Chaudhari leads Operon Strategist with a unique combination of technical expertise and strategic insight. Trained by top regulators from the USA and Europe, he expertly guides both domestic and multinational organizations through complex regulatory and quality assurance processes.
As part of the CITD program, a joint initiative between the European Commission and the Indian Government, Mr. Chaudhari has significantly contributed to raising awareness of European medical device regulations in India. Operon Strategist specializes in developing compliant Standard Operating Procedures (SOPs), implementing Quality Management Systems (ISO 13485, 21 CFR Part 820), and helping companies achieve essential certifications like 510(k) and CE Mark.
With a highly skilled team and a focus on delivering practical, compliant solutions, Operon Strategist remains committed to driving excellence and regulatory success in the medical device and pharmaceutical industries worldwide.
Dr. Anil Kumane, Ph.D. (Tech) in Pharmaceutical Sciences
Certified Lead Auditor for ISO 9001 and ISO 13485 | Diploma in Export Management | Certification in Statistical Quality Control
With 29+ years of experience in Quality Assurance, Regulatory Affairs, and Manufacturing, Dr. Anil Kumane has a profound understanding of the global regulatory landscape, covering regions such as the US, EU, UK, and Japan. He has successfully led the setup of Medical Device and Pharmaceutical plants, managed technology transfers, and overseen product development. Dr. Kumane’s expertise includes medical devices such as consumables, wound care, and nephrology, as well as hands-on experience in Gamma Sterilization Plant management, adhering to ISO standards.
As a dynamic leader, Dr. Kumane is committed to driving quality, ensuring regulatory compliance, and achieving operational excellence in the industries he serves.
Mrs. Lakshmi Ranjithkumar, Regulatory Manager
Master of Science (M.Sc) Biotechnology | PG Diploma in Patents Law | Certificate in Clinical Data Management
With over 15+ years of experience in the medical device regulatory industry, Ms. Lakshmi Ranjithkumar has expert knowledge of global regulations including U.S. FDA, SFDA, UKCA, TGA, EU MDR, and Indian CDSCO. She specializes in product approvals, including 510(k)s, EU MDR, and TGA submissions, and has extensive experience in 21 CFR Part 820, ISO 13485, ISO 9001:2015, and MDSAP audits.
Her expertise covers medical device design, development, manufacturing compliance, and quality system management, including design control, CAPA, and complaint handling. Ms. Ranjithkumar has successfully responded to FDA 510(k) deficiencies and supported combination device and drug submissions, ensuring regulatory success and compliance at every stage.