Vol 4 No 2 (2016): VOLUME 4, ISSUE 2, 2016 | International Journal of Drug Regulatory Affairs

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Review

COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL

Lincy Joseph, Mathew George, Kalpesh K Malaviya, Kalpesh K Malaviya, Bincy K Chacko, Jitendra Kumar Badjatya

Pages 1-9
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SOFTWARE AS MEDICAL DEVICE

Tejaswi P. Alekya, M.P. Venkatesh, Pramod Kumar T.M.

Pages 10-18
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REVIEW ON SPONSOR / APPLICANT MEETINGS WITH FDA: HIGHLIGHTS OF NEW GUIDANCE OVER EXISTING

Charmy Kothari, Kavina Shah

Pages 19-26
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Case Study

PROJECT MANAGEMENT VALUES DRIVEN IN PHARMA INDUSTRY

Swagat Tripathy, Bishnu B. Mohanty

Pages 27-32
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