Garima Singh

Experience

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  Central Drugs standards Control organization

  Jul 2008 - Apr 2013

  Technical Data Associate

  • Scientific/Technical evaluation of dossier submitted as per Common Technical Dossier (CTD) format for conduct clinical trial & market authorization of Biological products & New Drug.• Review of applications pertaining to New Drug Approval, Registration and Import license, grant of Test License and conducting clinical studies for the biological products in the country as per the provisions of Drug and Cosmetics Act & Rules, GCP guidelines & Schedule Y.• Evaluation of Global clinical trial application as per provisions of GCP guidelines & Schedule Y • To co-ordinate with other department within organization to carry out various regulatory activities & to provide support in the execution of regulatory activities by maintenance and updation of regulatory databases towards providing real time regulatory information on need, under the guidance and instruction of the senior officers. Show less

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  Zydus Cadila

  Jun 2013 - May 2018

  Deputy Manager (Regulatory Affairs)

  Review of applications pertaining to Marketing authorization, Registration and Import license, Test License and conducting clinical trials for the drugs & biological products.Review of applications of Registration for cosmetics.Compilation of the dossiers and Review regulatory application & submission of all required application pertain to company with full responsibility. Responsibility for close coordination.Regular follow-up with the Regulatory Authority for timely obtaining of all approvals. Show less

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  World Health Organization

  Jun 2018 - now

  Consultant