Email: bd@adaptisls.com; info@adaptisls.com
Email: bd@adaptisls.com; info@adaptisls.com
Mr. Dilip Shivale Founder and CEO
As Founder and CEO, Dilip has started the journey of Adaptis in August 2020 and keeping vision of leading a company to the globally recognized brand among pharmaceutical service industry. Dilip is an experienced regulatory professional with a demonstrated history of working in the pharmaceutical industry for more than 17+ years with regulatory experience of 150+ ANDA/NDA/IND/MA/ANDS including many first-to-file, NCE-1 ANDA and 505(b)2 applications.
He is highly skilled in the original US DMF/ANDA/NDA (USA)/ANDS (Canada), Product Qualification (WHO) and APIMF/MA (Europe) applications, amendments, supplements and eCTD submissions for various dosage forms such as solid orals, liquid orals, injectables, ophthalmic, soft gels, peptides, biologics, lozenges and gums.
He has established regulatory affairs department for new companies. With his thorough understanding of regulatory framework, he has successfully supported several new organizations from product development stage to dossier (ANDA/ANDS/MA) approval stage and regulatory site audit. He has vast experience of leading teams in large multinational, mid and small size companies, as well as service provider firms in various departments.
He has worked with several multinational pharmaceutical companies like VIATRIAS (Mylan), Aurobindo Pharma, Unichem Labs, Graviti Pharma and Pharmazone.
Mr. Pramod Choudhari Director of Operations
Pramod is experienced analytical chemistry professional with a demonstrated history of working in the pharmaceutical industry for more than 18+ years. He worked on analytical method development, validation and technology transfer for drug substance, drug product and New chemical entity molecules. He has in-depth knowledge and a solid understanding of quality systems and GMP/GLP/FDA/ICH and 21 CFR Part 11 regulations.
Before Adaptis, Pramod worked with leading pharmaceutical companies in India like, Lupin Limited, Emcure Pharmaceutical Ltd., Hikal Limited and Megafine Pharma Pvt Ltd.
He has experience of working on variety of regulatory projects and successfully delivered those projects to our clients. He has enriched Adaptis with his unique skills of team handling, operation managements and business development. Pramod is responsible for operations and business development at Adaptis Pharma.