Ipshita Chattopadhyaya

Dr. Ipshita Chattopadhyaya is a results‑driven Regulatory Affairs and Clinical Safety professional with over 8 years of experience supporting global clients in CE marking, EU MDR compliance, and lifecycle management of medical devices, combination products, and pharmaceuticals.

She provides strategic SME guidance across diverse international markets, enabling timely certification and sustained regulatory compliance. Her expertise spans Class I–III medical devices, including insulin delivery systems, defibrillators, surgical instruments, catheters and cannulas, respiratory care devices, orthopedic implants, combination and ophthalmic products. She is highly experienced in EUMDR‑aligned clinical evaluation, systematic literature reviews, risk management, post‑market surveillance, and high‑quality regulatory documentation, with additional strength in PSUR and ICSR reporting for FDA‑regulated drugs, ensuring adherence to stringent global timelines and quality standards.

In Celegence, she mentors multidisciplinary teams to deliver complex regulatory projects efficiently. Known for her strong client engagement skills, she consistently balances strategic oversight with hands‑on execution, fostering a culture of collaboration, accountability, and continuous learning. Ph.D.‑qualified in Pharmaceutical Sciences, with publications in peer‑reviewed journals, Dr. Chattopadhyaya is a trusted advisor to clients on regulatory strategy, compliance risk mitigation, and successful market access.