Prashant Dighe Email & Phone Number

Vadodara, Gujarat, India

Vadodara Area, India

Dosage forms- Injectable and Solid OralsUS Market:• Key role includes preparation of regulatory strategy notes, providing regulatory pathways, submission management and strategic input during developmental projects (Specification finalization, stability design, Q1/Q2 assessment, IIG etc).• Planning and submission of NDA/ANDA for US market and post approval activities.• Preparation/ Review of third party dossiers from RTR and approvability point of view and presenting to… Show more Dosage forms- Injectable and Solid OralsUS Market:• Key role includes preparation of regulatory strategy notes, providing regulatory pathways, submission management and strategic input during developmental projects (Specification finalization, stability design, Q1/Q2 assessment, IIG etc).• Planning and submission of NDA/ANDA for US market and post approval activities.• Preparation/ Review of third party dossiers from RTR and approvability point of view and presenting to management. • Management of Deficiency (CRL, IR, DRL) responses to pending NDA/ANDAs, supplements.• Evaluation and submission of Pre-IND/NDA meeting request and briefing package and arranging meeting with FDA.• Technical writing, review and timely submission of supplements (CBE-0, CBE-30, PAS and Annual reports). • Controlled correspondence submission to seek FDA’s advice on technical/regulatory requirements.US and CA Labeling: • Review and submission of labeling, SPL• Support in launch of new productsEU and CA Market:• Preparation of reg strategy notes.• Planning & submission of MAA (Hybrid and generic) & ANDS application and query responses. • Scientific advice submission to seek Agency’s advice on technical/regulatory requirements.New product Evaluation for US and OAM (EU, CA, AU and NZ) market:• Evaluation of possibility of extension of dossier from one market to another market.• Evaluation of additional requirements and documents. • Coordination with cross functional teams in order to deliver quality projects on time.• Training to various manufacturing sites on newly published FDA guidance’s and updated regulatory requirements.• Designing and creating various databases using proficiency in MS-Excel in order to track and retrieve regulatory information. • Active role in tracking compliance of manufacturing, testing sites in order to ensure approvals on time and their maintenance to meet.• Drug Master File (DMF) evaluation. Show less

Hyderabad Area, India

Navi Mumbai

Navi Mumbai

Bangalore

Aurangabad Area, India

M Pharm, Pg

B. Pharma