Dr Kashyap Wadekar Email & Phone Number

Ahmedabad, Gujarat, India

- Focus on the long-term vision and preparedness of the organization at all levels- Strategic planning for business development - Strategic financial forecast and business initiative at the corporate level.- R&D projects selections and review- Selection of new pipeline molecules and their require Technologies / Applications- Scientific assessment of New molecules- Product portfolio development- Review of molecules and ensure the right track scientifically up to the regulatory filing- Monitoring the system and strengthening- Quality Management, safety, and regulatory requirements

Ahmedabad Area, India

- Strategic planning for business development - Product portfolio development- R&D projects selections and review- Selection of new pipeline molecules and there require Technologies / Applications- Scientific assessment of New molecules- Review of molecules and ensure right track scientifically up-to Regulatory filing- Focus on long-term vision and preparedness of organization at all levels- Monitoring the system and strengthening- Quality Management, safety, and regulatory requirements- Strategic financial forecast and business initiative at the corporate level.___ BE A PART OF RELIANCE RASAYAN AND HELP US IN BUILDING A NEW YOU___Please contact usdrwadekar@rrplpharma.com, contact@rrplpharma.com, Web: www.rrplpharma.com

Hyderabad Area, India

- Select a pipeline of new molecule and evaluation for global market.- Evaluate Scheme, Process stream and Impurities profiles as per Regulatory requirements.- Evaluation of finalized molecules and ensure right track scientifically up-to Regulatory filing for UQUIFA Spain and Mexico.- Evaluation of product Lab feasibility to commercial level.

Hyderabad Area, India

- Selection and Evaluation of Products Scientifically.- Identify New pipeline molecules and proposes options with risk factor.- Select a pipeline of New molecule and priorities based upon business need.- Understand the underlying New pipeline molecules and there require Technologies / Applications.- Scientific assessment of New molecules & submit to Portfolio Management Executive Committee.- Evaluate Scheme, Process stream and Impurities profiles as per Regulatory requirements.- Evaluation of finalized molecules and ensure right track scientifically up-to Regulatory filing.- Evaluate status of Patent with IPR, Analysis with AR&D and Regulatory filing with DQA.- Product feasibility in lab and commercial level

Hyderabad Area, India

* Involved development of Non-Infringe API (process) and CRO project. * Involved on API’s impurities synthesis - isolation - characterization, related to USP, EP, BP and Non-Pharmacopical, stability for DMF/CEP filing and its regulatory queries.

Hyderabad

Hyderabad

* Expert in generic research (Organic chemistry) along with ability to collaborate with cross-functional teams in R&D and manufacturing.* Involved in new product development, execution of product knowledge and documentation.* Capable to generate standard scientific documents.*Skilled to reviewing and providing scientific justification to queries from regulatory agencies.* Able to analyze the data generated during process development / its impurities and interpret them.* Have well at interpersonal, leadership skills and able to manage the performance of team. * Involved development of Non-Infringe API (process) and CRO project. * Working on API’s impurities. Which are related to USP, EP, BP and Non-Pharmacopical, stability for DMF/CEP filing and its regulatory queries. Synthesized more then 200 impurities related to 15 APIs. * Have guide 10 Master Students for their projects in Organic Chemistry from Jawaharlal Nehru Technological University, Osmania University and Acharya Nagarjuna University, Hyderabad, AP (India)

Vadodara Area, India

* Involved for end-to-end development of Sucralose and APIs.* Worked with Dr. S P Phadnish (D.Sc), innovator of Sucralose.(Bio Arc Research Solutions, Alembic Ltd., )

Ahmedabad

* Gain R&D experience over developing contract research project involving critical chiral chemistry.* Developed different quaternary ammonium and phosphnium compounds and Phase Transfer Catalyst.

Ph.D, “Studies Of Some Medicinally Important Compounds As Potential Drugs”

Ph.D. on “Studies of Some Medicinally Important Compounds as Potential Drugs” in May 2002 from University Department of Chemistry.

Intellectual Property Rights

B. Sc., Chemistry

M. Sc., Organic Chemistry-Synthetic Drugs

First-class first position in M. Sc.

Post-Graduate Diploma In Pharmaceutical Regulatory Affairs (Pgdpra), Pharmaceutical Regulatory Affairs