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International Journal Of Drug Regulatory Affairs
Year 2023, Volume-11, Issue-4 (December)
Print ISSN : 2321-7162
Online ISSN : 2321-6794

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Review Articles

Overview of drug approval process and post approval changes in Europe
Sakshi A. Navale, Ganesh D. Basarkar

A review of registration and approval process of medical device in India and Japan
Shubham N. Kumavat, Lokesh P. Kothari, Atish S. Mundada

A review of herbal regulations and approval process in India and Europe
Manish B. Sahane, Ganesh D. Basarkar

Regulatory skeleton of medical devices in the european union
Soundarya Reddy Kalva, Sahitya Reddy Kalva, Haripriya

A review on approval and registration process of medical devices in Canada and India
Gaurav V. Patil, Ganesh D. Basarkar

Overview of good manufacturing practices requirements for herbal medicines in India and Europe
Kanchan H. Ram, Lokesh P. Kothari, Atish S. Mundada

A review on next generation eCTD - eCTD v4.0
Nikkitha Sudesamithiran

A comparative review on the regulatory framework of pediatric drugs in the US and EU: Challenges and recommendations
V. Sri Sowmya, Y.B Manjulatha, J. N. B Indusekhar, V. Bhaskar Raju

Navigating the regulatory landscape: Key trends shaping today's regulatory affairs environment
Bidhya Sharma, Anmol Gurung, Prena Pradhan, Depesh Darjee, Naveen Kumar Kotla

Product patrolling: Learning recall execution strategies through case studies
Ankita Bobhate, Piyush N. Bajare, Vinita V. Kale, Suankit A. Harane, Milind J. Umekar

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