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MANAGEMENT

GAVIS® has a Trusted Team of experienced professionals with
300+ years of generic pharmaceutical experience.

 

 

Scott Talbot
Vice President, Quality Assurance and Regulatory Compliance
Scott joined GAVIS Pharmaceuticals in November 2010 as Director of Quality Assurance & Regulatory Compliance and during his tenure, demonstrated leadership abilities which led to his promotion to Vice-president of Quality Assurance and Regulatory Affairs in Jan 2012. In this role, Scott oversees all quality operations for the Wintac and Somerset facilities and approves all communications with the FDA and other regulatory agencies. Scott is a seasoned Quality Assurance and Regulatory Affairs professional with over 25 years’ experience in pharmaceutical manufacturing and development. He has worked for several large pharmaceutical firms with increasing levels of responsibility and took the leadership role in presenting to the FDA District Offices in San Juan PR, Florida, Kansas City and New Jersey to bring facilities faced with Warning Letters, significant 483 and sterility concerns back into FDA compliance. His excellent track record with the FDA is a testament in his ability to foster teamwork and identifying the underlying Quality System issues. During his career, he has served as a Quality Professional for various industry stalwarts such as Baxter Healthcare, Bausch & Lomb Pharmaceuticals, Teva and Actavis in which he developed, implemented, managed, and streamlined the Quality Systems.
Bala Nayar, Ph.D.
Vice President, Specialty Product Development
Bala Nayar, Ph.D., joined Novel Laboratories/Gavis Pharmaceuticals in October 2012, heading up the Specialty Product Development department. He brings to Novel/GAVIS 30 plus years of pharmaceutical, OTC, healthcare and consumer product development experience and accomplishments. Over the years, Bala has been involved in product development from concept-to-market, project management, process development, scale-up and validation, clinical and bioequivalence studies, ANDA submissions and approvals, FDA Regulations, contract projects, due diligence, technical transfer and pharmaceutical business development. He has expertise in various dosage forms: semi-solids (ointments, creams, gels, pastes, and lotions), liquids and suspensions, suppositories, softgel capsules, tablets, nasal sprays, metered dose inhalers, sterile ophthalmic and injectable products. Prior to Joining Novel, Bala was Director of Product Development at Catalent Pharma Solutions where he led cross-functional product development teams at various U.S. and international Catalent sites and external partners for a portfolio of ‘high-barrier to entry’ generic drug products. Bala was Director of product development, process validation, technical transfer, clinical studies, CMC and contract projects at G&W Laboratories, a manufacturer of topical products and suppositories. Bala also worked as world-wide Director of R&D, Oral Care Products at Block Drug Co. (acquired by GSK), and at Procter & Gamble as a scientist and manager in technology, new product development and line extensions. Author of several publications and patents, Bala earned his Ph.D. in physical chemistry from Indian Institute of Science, Bangalore, India and did his post-doctoral research at the University of Southern California, Los Angeles.
Prasad Uppalapati
Vice President, Operations
Responsibilities: Planning, Purchasing, Manufacturing, Packaging, Engineering, Projects and Process scale-up. Background: Bachelors and Masters degree in Pharmaceutical Sciences. Prasad has 25 years of industrial experience in various leading pharmaceutical companies including: Lupin Laboratories, Ranbaxy Laboratories and Dr. Reddys Laboratories. Before joining GAVIS, he worked with Ranbaxy Pharmaceuticals Inc. for 11 years as the Senior Director Manufacturing responsible for the complete Manufacturing and Packaging operations of the company’s facilities in the U.S.A. He was a key member in the several multimillion-dollar expansion projects and played a pivotal role in planning, execution and commercialization of the plants in New Jersey and New York. During his tenure at Ranbaxy, he was directly involved in commercialization of multiple key Para IV filings of the company under exclusivities over the last seven years. Prasad is adept in projects planning, team building, scale-up and process optimization, automation leading to efficiencies, adapting various tools like SAP, Documentum, Trackwise and LMS in the operations function to enhance productivity and compliance.
James Garegnani
Director, Product Development
James Garegnani joined GAVIS Pharmaceuticals in August 2010 as Director, Product Development. With over 35 years experience in Pharmaceutical Research, including Product Development, Process Development, Technical Support, Technology Transfer, and Marketed Product Support of Solid and Liquid Dosage Forms, his career has given him a broad experience in development of generic, branded and OTC products. He has led cross-functional teams in managing multiple projects in an inter-departmental environment, has extensive experience in contract development and manufacturing, and has been a pioneer in developing modified release dosage forms – an area in which he is co-author of four patents. Prior to joining GAVIS, James was Director, Formulation and Process Development for KV Pharmaceutical with responsibilities for formulation and process development as well as managing two GMP pilot plants. Before leaving KV, James was responsible for establishing quality systems and procedures – including QbD and risk management – to ensure regulatory compliance for all product development activities in accordance with FDA and ICH guidelines as part of a quality management system. James earned his Bachelor in Chemistry degree from Monmouth College and has taken several management courses (MBA) from Southern Illinois University.
Aman Trehan, Ph.D.
Director, Intellectual Property
As Director of Intellectual property at Novel, Aman manages IP-related litigation which includes litigation strategy, interfacing with and supporting outside litigation counsel, and managing discovery and depositions. Aman also oversees Novel’s IP portfolio and leads IP-related due-diligence in the context of ANDA filings and supports business teams in identification of product opportunities.
Prior to joining Novel, Aman was the general manager of global intellectual property & strategic planning at Wockhardt, India, and prior to that he was head of intellectual property at the Pharmaceutical Technology Centre at Zydus, India. In addition to his time at Wockhardt and Zydus, he also worked at Alembic Pharmaceuticals and Ranbaxy Laboratories Limited.
Aman has completed specialized coursework pertaining to patent law in the U.S. and Europe. He is the recipient of the Pharmexcil Patent Award given by the government of India. He holds a doctorate in pharmaceutical sciences from Panjab University, Chandigarh, India.
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