Regulatory Advisory Withdrawal & Policy Correction
Structured legal and technical representations where an advisory, notification or administrative position creates material policy inconsistency.
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TLGS Group
Shri Rajesh P. Chaudhari
Former Assistant Commissioner, Food and Drugs Administration, Maharashtra State
Regional Principal Advisor
Pharmaceutical Regulatory Affairs, Licensing & Compliance (Maharashtra)
Former Assistant Commissioner, FDA Maharashtra, with more than three decades of experience in pharmaceutical regulation, licensing, inspections, quality systems and regulatory administration.
Professional profile
Shri Rajesh P. Chaudhari brings more than 34 years of combined pharmaceutical-sector and regulatory experience to TLGS. His service with the Food and Drugs Administration, Maharashtra State, extended from 1993 to 2025 and included the position of Assistant Commissioner in the Thane region. Earlier assignments covered Pune, Greater Mumbai, the Intelligence Branch and divisional responsibilities in Konkan, Mumbai and Nashik.
His regulatory experience spans manufacturing and sales licensing, premises-plan approvals, inspections, enforcement and pharmaceutical quality. He participated in joint WHO-GMP audits with the Central Drugs Standard Control Organisation and in risk-based inspection and national sampling programmes. Earlier pharmaceutical product-management and diagnostics roles add an operational perspective to his regulatory background.
At TLGS, he serves as Regional Principal Advisor for Pharmaceutical Regulatory Affairs, Licensing & Compliance in Maharashtra. His remit strengthens the national healthcare and pharmaceutical practice through state-specific regulatory interpretation, licensing review, inspection preparedness and compliance remediation. Cross-state or central-regulatory assignments are considered where his experience is relevant.
His advisory focus includes applications and submissions, responses to regulatory observations, corrective and preventive action planning, standard operating procedures and training. The emphasis is on documented readiness, practical regulatory interpretation and continuity across regulated healthcare operations.
Experience & distinction
- Former Assistant Commissioner, Food and Drugs Administration, Maharashtra State — Thane
- FDA Maharashtra service across headquarters, intelligence and divisional assignments, 1993–2025
- Participation in joint WHO-GMP audits with CDSCO and risk-based inspection programmes
- Experience in pharmaceutical manufacturing and sales inspections, licensing and premises approvals
- Recipient of the Best Drug Inspector award at an AIDCOC annual conference and the FDA Person of the Year award from IPC Trust, Pune
Education & qualifications
- B.Pharm., Pune University
- MBA, Marketing, IMED Bharati Vidyapeeth, Pune University
- Certified Independent Director, Indian Institute of Corporate Affairs
- Specialised training in vaccines and sera production at Central Research Institute, Kasauli, and risk-based auditing and sampling at National Institute of Biologicals
Specialist practice
Pharmaceutical & Healthcare Regulatory Affairs
Connect licensing, inspection readiness and national operational compliance with the relevant TLGS expertise.
Explore the healthcare regulatory practice →State-specific pharmaceutical expertise within TLGS’s national healthcare regulatory practice.