Dr. M. Ganesan is the Founder and Managing Director of KMS Health Center Pvt Ltd. He holds a Ph.D. in Applied Sciences from the College of Engineering, Anna University, Chennai. Dr. Ganesan, a first-generation entrepreneur.
He established his research and development center in 2005. With extensive experience, he specializes in setting up R&D facilities for clinical research, formulation, and API development in the pharmaceutical and biotechnology sectors.
Ms. Vasanthi is a dynamic professional heading Project Management at KMS Pharma. With an MBA and extensive experience in her field, she excels in overseeing formulation development, tech transfer, and dossier development for various regulatory bodies, including the USFDA.
Under her strategic leadership, KMS Pharma's projects are consistently well-executed and delivered on time, ensuring compliance and quality. Her expertise and managerial acumen make her an invaluable asset in driving the company's success and maintaining its reputation for excellence in the pharmaceutical industry.
Dr. Rajeev Soni, with a Ph.D. in Pharmaceutics, is a seasoned pharmaceutical leader with over 19 years of industry experience. He has excelled in drug product development, technology transfer, and lean manufacturing, contributing to successful patent filings and on-time launches.
Dr. Soni has authored CMC documents and CTDs for global ANDA submissions and has worked with top pharmaceutical companies. His expertise includes managing complex generics, strategic ANDAs, regulatory interactions, and conducting audits for USFDA, UKMHRA, WHO, DSIR, and MOHAP, alongside project management, and staff training.
Mr. N Murali is is a seasoned pharmaceutical leader with over 34 years of experience in formulation development across various dosage forms, including oral solids, sterile products, and topicals. He has expertise in platform technologies like MUPS, hot melt extrusion, and nasal sprays, with 21 patents to his name.
Mr. Murali has successfully led complex generics development, NDDS innovations, and regulatory filings in global markets, Mr. Murali’s extensive expertise will help KMS Pharma enhance its R&D capabilities, drive innovation, and achieve regulatory success in global markets.
Mr. S. Lakshminarayan is the AGM – Injectable Formulation Lead at KMS Pharma, Chennai, with extensive experience in formulation development. He has led teams in developing sterile dosage forms, managing regulatory filings, and addressing commercial production challenges for global markets.
He holds a Master’s and Bachelor’s in Pharmacy from Dr. MGR Medical University and has a proven track record of responding to regulatory queries and ensuring compliance with quality standards.
Mr. Shankar Karlekar is a seasoned pharmaceutical professional with over 20 years of expertise in Analytical R&D, specializing in analytical method development, validation, and regulatory compliance for global markets, including the US and Europe.
He has successfully led analytical teams in the development of niche formulations, life cycle management, and regulatory submissions. His core competencies include risk assessment for residual solvents, elemental impurities, and nitrosamines, as well as stability studies, method transfer, and regulatory query resolution.
With extensive experience across top pharmaceutical companies, Shankar has been instrumental in ensuring robust analytical support for formulation development, dossier submissions, and regulatory approvals. His expertise in QbR, cGMP/cGLP, and plant OOS/OOT investigations makes him a key asset in accelerating drug development and commercialization.
At KMS, he drives analytical excellence, ensuring compliance with USFDA and global regulatory standards, while optimizing analytical methodologies to support complex and high-value pharmaceutical formulations.
Dr. Veerabhuvaneshwari V. is a highly accomplished biotechnology and pharmaceutical professional with expertise in Quality Assurance, Regulatory Compliance, and Process Validation. A Gold Medalist with a Ph.D. in Biotechnology and an M.Tech in Biopharmaceutical Technology, she has over a decade of experience spanning academia and pharmaceutical R&D.
As a Lean Six Sigma Black Belt-certified expert, she specializes in bioanalytical techniques, OOS/OOT investigations, GMP compliance, and statistical process control. She has played a pivotal role in aligning quality systems with USFDA and global regulatory standards. Dr. Veerabhuvaneshwari has collaborated on industry-academic projects, secured research grants, and holds multiple patents. She has also authored several publications in pharmaceutical sciences, reinforcing her thought leadership in regulatory excellence and quality-driven drug development.