Gautam Halder
3 SlideShares 3 Followers
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Organization / Workplace
Surat Area, India India
Occupation
at Alkem Laboratories Ltd.
Industry
Medical / Health Care / Pharmaceuticals
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dmf submissions usfda user fee gdufa self identification electronics drug master file pharmaceutical ectd modules review usdmf regulatory affairs
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Presentations

(3)

USDMF Preparation and Submissions

7 years ago • 4097 Views

eCTD Submissions

7 years ago • 2238 Views

Self identification

7 years ago • 764 Views

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(8)
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EU - Regulatory Evaluation Process

Pradeep Gangavaram • 13 years ago

Marketing authorization procedures in eu

RajaniKarpur • 13 years ago

Registration procedure of drugs in european union

bdvfgbdhg • 12 years ago

EU and US Procedures for API Registration - Commonalities and Differences

Merck Life Sciences • 5 years ago

US DMF v/s European DMF

Neha Pillai • 8 years ago

Drug master file

Bindu Kshtriya • 8 years ago

Marketing Authorisations in the EU: The Centralised Procedure

Office of Health Economics • 8 years ago

US DMF Preparation and submission

Bhanu Chava • 10 years ago
Personal Information
Organization / Workplace
Surat Area, India India
Occupation
at Alkem Laboratories Ltd.
Industry
Medical / Health Care / Pharmaceuticals
Tags
dmf submissions usfda user fee gdufa self identification electronics drug master file pharmaceutical ectd modules review usdmf regulatory affairs
See more