LGM Pharma
Shailesh Vengurlekar has a strong background in the pharmaceutical industry, with a particular focus on quality control, regulatory affairs, and product development. Shailesh currently holds the position of Senior Vice President of Quality and Regulatory Affairs at LGM Pharma. Prior to this, Shailesh served as Vice President of Pharmaceutical Development at Palatin Tech, where they oversaw the development of Active Pharmaceutical Ingredients (API), drug products, and associated processes. Shailesh also played a key role in establishing a regulatory strategy for a New Drug Application (NDA) submission and managed non-clinical development studies.
Before joining Palatin Tech, Shailesh was a Manager at Ranbaxy Pharmaceuticals, where they played a crucial role in setting up controlled substances systems across multiple sites and implemented a program to monitor training across different divisions.
Earlier in their career, Shailesh worked at ABC Laboratories, Inc as a Manager/Principal Scientist, responsible for project management, method development, and validation, as well as managing the Bioanalytical and Animal Health divisions. Shailesh also gained experience as a Pharmaceutical Scientist at Interx Pharmaceuticals, where they conducted assay development and routine analysis for formulation and development groups.
Shailesh started their career as an Analytical Development Scientist at Goodlass Nerolac Paints Ltd. Overall, Shailesh's work experience spans over several decades and covers various aspects of pharmaceutical development and regulatory affairs.
Shailesh Vengurlekar began their education history by attending the University of Bombay from 1973 to 1979. During this time, they focused on the field of study in Chemistry. Following this, from 1986 to 1991, Shailesh pursued their education at the University of Kansas, where they studied Chemistry and Business. Finally, from 1994 to 1999, they attended the University of Missouri-Columbia, specializing in Analytical Chemistry. No specific degree names are mentioned in the provided information.
LGM Pharma
LGM Pharma is a leading CDMO provider of comprehensive API sourcing and drug product contract development and manufacturing solutions to the pharmaceutical industry. We secure and optimize your supply chain with our extensive qualified API partner network, global drug product development and manufacturing facilities, and regulatory and market intelligence services delivering customized solutions that get your products to market faster. Full-service, expert support that accelerates the new product pathway. Now that’s smart. • Established in 2005 • ISO 9001-2015 QMS certified company • CGMP systems in accordance with ICH Q7 • Main business segments: R&D / Biotech / CDMO / Specialty Pharma Companies, New Drug Delivery Technologies (NDA/505b2) – with heavy concentration on injectables, transdermal, nasal, inhalation, ophthalmic & sublingual drug deliveries Our products originate from our API manufacturing partner sites who are approved by the leading regulatory authorities, such as the US-FDA, EDQM, TGA, UK-MHRA, PMDA etc. LGM’s industry experience enables us to support our clients throughout the entire pathway of drug development, from discovery through commercial production. Based on the scale and scope of development projects with which we are involved, we are able to provide our customers with a seasoned perspective and valuable market insight. LGM Pharma has enhanced its position as a leading supplier of newly approved APIs, including full technical documentation and regulatory support. Our Clients: At LGM Pharma, our clients’ needs are our top priority, and we support our client base consisting of a diverse array of pharma companies, including: • Contract Research, Development & Manufacturing Organizations • Specialty Pharma and Novel Drug Delivery Systems • R&D & Biotech Companies • Generic Pharma Companies • Chemical Catalog Companies • OTC & Private Label Manufacturers • Academic & Government Laboratories • Pharmacy Compounding Industry