Understanding Drug Master Files (DMFs): Purpose, Types & Global Importance
Ipshita Chattopadhyaya
24 Jun, 2025
Dr. Ipshita Chattopadhyaya is a regulatory affairs expert with over eight years of experience, specializing in medical devices. She has extensive expertise in clinical evaluation and compliance with EU MDR 2017/745, covering a range of therapeutic areas, including ophthalmology, orthopedics, and hematology.
At Celegence, she leads the development and review of high-quality regulatory documents, ensuring compliance with MEDDEV 2.7/1 Rev. 4 and MDR requirements. She is also experienced in systematic literature reviews, risk management, and post-market surveillance.
Dr. Chattopadhyaya holds a Ph.D. in Pharmaceutical Sciences and has authored scientific publications in leading journals. Her regulatory knowledge and industry experience enable her to provide strategic guidance on medical device compliance and regulatory submissions.
Other Related Articles
09 Jun, 2025
05 Jun, 2025
29 May, 2025