Rakesh Dash Email & Phone Number

Telangana, India

• Led the creation of product roadmaps, outlining the development strategy and timelines for successful product launches.• Conducted market research and competitor analysis to identify profitable pharmaceutical products for overseas markets.• Collaborated with cross-functional teams to evaluate the Cost of Goods Sold (CoGS), ensuring cost-effectiveness in product development.• Performed financial evaluations, including project cost calculation, evaluation of Cost of Goods Sold (CoGS), IRR and NPV analysis, and support for Business Case/Forecasting.• Participated in pre-Apex & Apex discussions to present product proposals and ensuring successful product selection.• Proficient in IMS, MIDAS, Cortellis, IPD Analytics.• Conducted scientific feasibility evaluations to assess the viability of differentiated products, based on market trends and scientific understanding. • Performed gap analysis to identify resources and timelines required for dossier filings in target countries, leading to successful product launches in India and EM Leverage.• Support the BD team by identifying partners, preparing scope notes, and offering due diligence support for In-licensing/Collaboration, Out-licensing, Authorized Generic Opportunities, and Brand Buy Opportunities.

Pune, Maharashtra, India

• Responsible to explore various options and feasibility analysis to execute the projects with desired quality standards, to interact with CMO to understand project requirements for three ophthalmic products for US market and two dermatological products for IRF market, Gap analysis of products to be transferred and assist them in execution of projects. • Responsible to ensures the achievement of the project objectives (quality, costs, deadlines, customer satisfaction) and monitors project status to make sure everything stays on track, anticipates changes, risks and identifies appropriate actions, coordinates all functions involved inthe project (process development, manufacturing, quality control, regulatory affairs…), making the minutes for meeting and acts as the primary customer interface.• Milestone based review for invoice generation by CRO.• Responsible for initiating, planning, executing and monitoring of animmediate release BCS class III drug having voltage gated potassium channel blocker activity for US, EU markets. • Coordinating review meetings with plants for proper execution of the projects for scale up, optimization, exhibit batches and other miscellaneous development. • Tracking of various licenses i.e., reference samples import licenses, test licenses, DCGI permission and subsequent product licenses.

Pune, Maharashtra, India

• Involved and managed project teams to optimized process development and scale-up of a multiple-unit controlled release pellets formulation at commercial scale (1300L FBE), also involved in query response of the same• Designed and developed a Para IV first to file in-situ gelling technology based ophthalmic nonsteroidal anti-inflammatory drug (NSAID) formulations• Designed and developed a Para IV NCE-1 immediate release anticonvulsant medication with DS from BCS Class II• Designed and developed an immediate release BCS class II drug having broad-spectrum anthelmintic activity• Development of above product involved formulation stability, excipient/container closure compatibility, QbD to formulation/processdevelopment, writing development report and query response• Coordinated activities with various departments such as analytical, regulatory, quality control, API manufacturing and production• Involved in redevelopment of an approved Oral suspension • Involved in development of an Ophthalmic gel formulation for a corticosteroid with potent anti-inflammatory effects.• Involved in development of two topical dermatological products for Indian regionsmarket, also involved in the response for market complaints for earlier filed products in US market.

Pune, Maharashtra, India

Formulation and Development of IR Formulation of BCS Class I, II, IV molecule, Prolonged Release formulation for EU filing, First to file of Extended Release Capsule with QbD. Insitu gelling and micro emulsion based Ophthalmic preparations. Development of fixed dose combination product for Australia market.

Gurugram, Haryana, India

Formulation development of IR BCS II, bilayer antiretroviral, formulation and Development of low dose drug using compaction process, coordination with external customers for product development and scale up, exhibit batches.

Pune

Experience in Compression of Sustained Release MUPS (Pellets) from development to Scale up and exhibit.

M.Pharm, Pharmaceutics

Bachlor In Pharmacy, Pharmacy