Boddu Ganesh
regulatory affairs
- Role
- Regulatory Affairs, Visakhapatnam, India at Eisai Inactive Page
- Location
- Visakhapatnam, IN
- LinkedIn followers
- 500 followers
About Boddu Ganesh
MAAs/ANDAs/DCGI submissions/Variation filings in CTD/eCTD/NeeS format for both API & …
Experience
Regulatory Affairs, Visakhapatnam, India
Sep 2012 — Present · Visakhapatnam, IN
Review & compilation of regulatory Dossiers (DMF’s & Product quality) in CTD/ eCTD/NeeS format for markets (US/EU/Japan/ASEAN/WHO). Good practice in publishing & validating dossiers in eCTD by Lorenz & Pharmaready softwares.Updation of registration dossiers of existing DMF’s, evaluation of the Deficiencies received from respective agencies and timely reply. Responsible for all DCGI (Indian drug regulatory authority) Submissions including new drug approvals, clinical trail applications, site registration, required licenses from State drug control administration. Preparation for New Drug Advisory Committee (NDAC) presentations to be presented for approval of Clinical trials and New Drug Applications (NDA). Query responses for all DCGI queries related to New Drug and clinical trial applications.
Education
Delhi University
M-Pharmay
Bapatla college of pharmacy
Bachelor of Pharmacy (BPharm)
Skills
- Pmda Filing
- Regulatory Submissions
- Regulatory Requirements
- Regulatory Affairs
- Anda
- Import & Export Business
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