Prashanth Narwade Email & Phone Number

Mumbai, Maharashtra, India

Bangalore

Bengaluru, Karnataka, India

Mumbai, Maharashtra, India

Supporting and Obtained favorable outcome through SEC meetings for timely launch of sNDA and line extension Working on registration projects to obtain most rapid & optimal registrations of new products and all variations including manufacturing site change, indication change etc.Provide regulatory expertise and input into cross-functional Affiliate.

Mumbai Area, India

Key Roles:-Timely launch of new drugs and line extensions (NDA & sNDA):Ensure file readiness per agreed timelines for timely submission-Maintenance of regulatory licences:1.Renewal applications (RC, IL and Test license) and ensure file readiness for timely submission.2. Provide Regulatory documentation support for achieving targeted growth from.

Mumbai Area, India

• Key Roles:
• Preparation of Dossier & Registration of New Drug Application Imported from regulated countries like Japan, Europe, USA, Italy for manufacturing, marketing, distribution & initiating clinical trials in India.
• Application and approval of Test license form DCGI involved in clearance of CDTL testing and custom clearing of imported drug.
• Preparation of Dossier and Registration of Medical devices imported form regulated market.
• Renewal application of Import license, registration of manufacturing site and repacking permission.
• Query responses for post DMF Submission queries, NDAC queries.

Mumbai Area, India

• Key Roles:
• Investigating by using risk management tool (Failure Mode and Effective Analysis)
• Handling Of Change Control And DeviationPreparing and maintaining of:
• Annual Product Quality and Product Performance Review
• Manufacturing review of Out Of Specification and Out Of Trends
• Pack line validation protocol and reportMonitoring:

Akola

• Key Role:Accountable for carrying out all shop floor activities including in-process checks and line clearance at all stages of Manufacturing and Packing for solid, liquids, ointments & powder.
• Packing Material Specifications
• Certificate of analysis report for packing material
• Material Receipt Voucher

Aurangabad Area, India

• Roles:
• Handled packing activities as per scheduled plans and monitored the quality and productivity of products at all stages of Packing (Blister, Bottle, Injections and Cold Wallet Sealing )
• Reviewed and documented batch packing record and sequential log
• Managed manpower during each shift working
• Monitored and maintained calibration reports of equipments, supported the QA team during qualifying the equipment’s and pack line validation

Bachelors Of Pharmacy, Pharmaceutical Sciences

Activities and Societies: Participated in Blood donation camp and National Service schemeExceeded in learning advances in Pharmaceutical.

Higher Secondary, Biology/Biological Sciences, General

Activities and Societies: Participated in science exhibition for poster presentation on wind millPrepared a theoretical project on nervous.