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International Journal of Drug Regulatory Affairs (IJDRA)
Year 2018, Volume-6, Issue-2 (June)
Print ISSN : 2321-2162
Online ISSN : 2321-6794

Table of contents

Review Articles

A Comprehensive and Comparative study of qualification process for Drug Development tools in US, Europe, Japan and India
Garima Kshatriya, Dilip G. Maheshwari

Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU
Philip Saddik, John Pappan

Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania)-A Review
Randeria Juhi, Ronak Dedania, Zarna Dedania, Vineet Jain, Danej Meghna

Current Regulatory requirements for Registration of Nutraceuticals in India and USA
Pooja N. Jain, Meera H Rathod, C Vineet Jain, S. M. Vijayendraswamy

Regulatory requirements for the approval of Anti-Cancer drug (Mercaptopurine)in Myanmar as per ACTD
Meera H. Rathod, Pooja N. Jain, Vineet C. Jain, S.M. Swamy Vijyendra

Regulatory requirements for Drug master file in context to Canada and Australia
Danej Meghna, Ronak Dedania, Sanket Gandhi, Randeria Juhi, Kankrej Gaurav

A retrospective study of Warning Letters issued by US FDA over 2015–2017
Lakshmi Ananth, Nirmal K. Gurbani, Saurabh Kumar, Bharat Gujavarti

Regulation of Medicines in Bhutan: Current Status, Challenges and Opportunities
Pelden Chejor, Jigme Tenzin, Jigme Dorji

General requirements for marketing authorization transfers in Thailand, Malaysia, Singapore, Indonesia and Philippines
Prathyusha Jeeva, Jyothshna Devi Katamreddy

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