Abhishek Roy Email & Phone Number

India

Ahmedabad, Gujarat, India

Bengaluru, Karnataka, India

 Dossier authoring (Module 1, 2 & 3) as per eCTD requirements for initial submission in EU (Non-sterile), US (Non-sterile) and AU (Sterile) market for different dosage forms such as Immediate release (film-coated & uncoated) tablets, Hard gelatin Capsules, Oro-dispersible Tablets, Gastro resistant Tablets, Powder for Oral Suspension, Oral Solution, injection, eyedrops etc. Preparing responses to the queries sent by the EU/US/AU regulatory agencies and submission of responses within stipulated time. Preparing document checklist for dossier compilation and document retrieval from respective cross-functional departments (e.g. RnD, Plant, QC, QA, Clinical etc.) Review of technical documents (Product development report, Batch manufacturing documents, MFR, Specification of drug product & raw materials, Process validation documents, hold time study protocol & report, Stability protocol & report, Dissolution profile etc.) for ensuring compliance before compilation of dossier. End to end interaction with regulatory partners and responsible for organizing meetings in synergy with the business development team for timely submission of dossiers. Regulatory assessment and approval of Change Controls through QAMS as part of Change Control Management System Review of artworks for regulatory submission. Working on pharmaREADY software to prepare eCTD dossier. Regulatory submission via CESP (EU Market), MHRA portal (UK Market), ESG gateway (US Market) and GovTeams (AU Market). Submission of Controlled Correspondence to FDA through CDER NextGen portal. Pre Submission (PPF) and GMP clearance application through TGA eBS portal.

Bangalore

Bangalore.

Ambernath, Mumbai.

Worked as M.Pharmacy Project Trainee on Formulation Development and Hands on experience for the following formulation equipments at R&D scale;- Fluid Bed Processer (Glatt GPCG 1.1)- Wurster coating- Rapid Mixed Granulation- Roller Compaction- Tablet compression- Bilayered tablet compression- Film-coating - Extended release coating- Material dispensing process- Blending (OGB, DCB, Bin blender)

Master'S Degree, Pharmaceutics, Cgpa:- 9.01(85%).

Bachelor Of Pharmacy, Pharmacy, Cgpa:- 8.98(84.8%).

H.S(+2 Science), 80%.