Personal Information
Organization / Workplace
New Delhi Area, India India
Occupation
SENIOR SCIENTIFIC AND REGULATORY AFFAIRS ASSOCIATE at REGULATORY WISDOM
Industry
Medical / Health Care / Pharmaceuticals
About
Drugs and Cosmetics:
 Guidance for development of new products and technical data generation for in line with country specific registration guidelines.
 Handling technical queries/deficiencies from regulatory authority (from DCGI).
 Import registration of Pharmaceuticals in India.
 Preparation of Dossier (mainly clinical and non clinical report) with specific requirements like Well Established Use application, Hybrid application, Generic application.
 Review of quality documents (closed and open part of quality documents),
 Review of label of Drugs as per guidelines of Drugs and Cosmetics Act 1940 and Rules 1945.
 Experience in conversion of prescription drugs to nonprescription d...
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