Vishakha Niman

• Learned about analytical equipment used in pharmaceutical industry (HPTLC)
• Achievements

• Learned about FRD and ARD operations
• Achievements

A. CDSCO

Coordinate and ensure timely submission of regulatory applications pertaining to all imported/local manufactured products (including Biopharma & Medical Devices) to Health Authority, such as

· SND- Subsequent New drug applications.

· Registration Certificate applications (Renewals & Amendments).

· Import License (Form 10) applications (Renewals & Amendments).

· Post approval changes.

· Responses to Health Authority queries.

· Submission of samples/documents/applications to authorities other than Office of DCGI (state FDAs, CDTL, NIB, etc.)

· Medical Devices: Import medical devices (Form MD-15) renewal & variations application to Health authority.

· Periodic follow-up with relevant Regulatory authorities for issuance of approval for ongoing applications.

· Manage PSUR planning, submission and update Veeva/RIMS database as per applicable timelines.

· Create/Update/Review/Approve artworks for Imported products in WebCenter system.

· Review/Approve Pack insert, Artwork, Promotional material of Import/local manufactured products per local procedure.

· Review/Approve/Upload TrackWise (TW) database requests.

· Review/Approve/Upload Mango system database requests.

· Review/Update Regulatory Information Management System (Veeva RIMS) database for local and Imported products.

· Support other Regulatory activities/tasks, as assigned.

B. State FDA

· Renewals & Amendments of Manufacturer Loan Licence (25A/28A), Wholesale Licence (20B/21B), IMC, MSC, COPP & NCC certification application.