Anandarup Datta
Pharma R&D Leader | End-to-End Formulation & Analytical Development | 100+ Regulatory Filings | BE Studies | CPPK | Tech Transfer | Packaging & IP
- Role
- Head R & d at Bliss GVS Pharma Ltd.
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Anandarup Datta
Innovation in formulation isn\'t just about creating medicines—it\'s about redefining the…
Experience
Head R & d
Jun 2017 — Present · Mumbai, IN
Driving strategic R&D operations across F&D, A&D, tech transfer, regulatory, and IP for US, EU, UK & RoW markets with focus on innovation, compliance, and product readiness for global filings and launches.Strengthened R&D infrastructure and expanded team capability for regulated market complianceDirected end-to-end lifecycle for ANDA, EU, and UK submissions across multiple dosage formsEnabled seamless technology transfer through robust collaboration between formulation and plant teamsChampioned CPPK, IP, and Regulatory functions for aligned and timely global product launchesOrchestrated documentation, bio-study readiness, and cross-functional planning for on-time filing and approvalsANDA & EU/UK Filings, Technology Transfer, Regulatory Strategy, CPPK Management, Intellectual Property, Global Project Coordination
Education
Jadavpur University
M Pharm, Pharmaceutical Technology
Jadavpur University
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Technology
NIBM
EMBA
2014 — 2015
Skills
- Formulation
- Drug Delivery
- Generic Programming
- R&D
- Medical Writing
- Dissolution
- Anda
- Technology Transfer
- Hplc
- Pharmacology
- Regulatory Affairs
- Glp
- Pharmaceutics
- Validation
- Regulatory Submissions
- Quality by Design
- Sop
- Drug Discovery
- Uv
- Analytical Chemistry
- Pharmaceutical Industry
- Gmp
- V&V
- Regulatory Requirements
- Cleaning Validation
- Chromatography
- Fda
- Drug Development
- Uv/Vis
- Lc-Ms
- Capa
- Pharmaceutical Research
- Ir
- Product Development
- Life Sciences
- Pharmacokinetics
- Clinical Trials
- Management
- Abbreviated New Drug Application (Anda)
- Standard Operating Procedure (Sop)
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