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Dr.Vijay Kulkarni (M.Pharm Ph.D)

Co-Founder, Director, Formulation & Business Development

Experience more than 16 years in pharmaceutical research & development of solid oral dosage forms, out of which 11 years’ experience in Hot Melt Extrusion Technology. He was a Postdoc research scholar at Dr. Michael Repka’s lab, University of Mississippi, USA, working on Hot Melt Extrusion for various application.

Expertise and Research Area: Development of pharmaceutical and nutraceutical using HME for solubility enhancement, modified release formulation, taste masking, nanoparticles, continuous granulation for IR and ER products, semisolid dispersions, and Effervescent.
Rising Star Award in F&D for contribution in “Continuous Granulation”, presented during FDD 2019 Conclave, Hyderabad by Indian Express.  
 

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Rameshwar Nalawade (MSc. Analytical Chemistry)

Co-Founder, Director, Analytical, Quality and Corporate Strategy

Experience more than 22 years in pharmaceutical industry for Analytical Development and Quality.

Expertise and Research Area: Analytical Development of NCE’s, Characterization of Hot Melt Extrudates and different types of formulations. Developed and optimized analytical tools for monitoring materials produced through continuous manufacturing by Hot Melt Extrusion.

Technical Transfer: Involved in strategies for Technical transfer of Analytical Methods from Research and Development to commercial manufacturing site.

Has spent over 2 decades with leading Indian pharmaceutical companies, (Ipca, Zydus Cadila, Piramal and STEERLife). 

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S. Narasimha Murthy (Ph.D., FAAPS)

Scientific Advisor

Dr. Murthy provides expertise in formulation development, characterization and IVPT And IVRT. He has two USFDA contracts to conduct research on Q3 characterization and IVPT protocol.  He was a Professor at the University of Mississippi for over 15 years. Transcutaneous drug product development using HME and other technology are one of the main areas of his research. 

He is recipient of New Investigator award and Cumberland Researcher of the year from University of Mississippi, Global Indus Technovator award from MIT, Inducted as the Fellow of American Association of Pharmaceutical Scientists in 2017 and was honored with Distinguished Scientist award by American Association of Indian Pharmaceutical Scientists, recognized as “Eminent Scientist” from Association of Pharmacy Professionals, bestowed with “Pharmaceutical Global Health Award” by the AAPS. 

He has published over 150 research papers, over 200 scientific posters in various national and international level, authored two books and over fifteen book chapters. He has been funded by NIH, USFDA and Pharmaceutical companies.
 

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Dr. Girish Kumar Jain (M.Pharm, Ph.D.)

Scientific Advisor

Experience: Rich professional Experience of 27+ years in development and filing of different dosage forms. Filed about 250 ANDAs and 505(b)(2) NDAs with US FDA and 50+ generic products in Europe and 25+ in Australia. 

Experience of developing and filing various dosage forms including Solid Orals, Liquid Orals, Sterile dosage forms (Injectable and Ophthalmic), Topical and Transdermal Delivery system and extensive experience in Modified Release dosage forms development. He has expertise in correlating R&D development with commercial viability.

Dr. Girish has 32 granted patents in US and 150+ patents in Europe. He was awarded Chairman’s Trophy for approval and launch of the product and was involved in filing and approval of multiple FTFs.

Currently he is working at Cochlea Pharma, Mumbai, in past he has worked in Slayback Pharmaceuticals Inc., Alkem Laboratories Ltd, Wockhardt Limited, Ranbaxy Research Laboratories, Gurgaon at various capacity as President, Head of Formulation Development etc. He has multiple Scientific Publications, Presentations and Patents at National and International Journals level.

Are you in search of HME technology for your Pharmaceutical Products Development?