Adaptis Pharma Private Limited
Dilip Shivale is an expert in regulatory affairs and has extensive experience leading various departments in the pharmaceutical industry. Currently serving as CEO & Founder at Adaptis Pharma Private Limited, Dilip has held key positions at companies such as Pharmazone, Graviti Pharmaceuticals, AUROBINDO PHARMA LTD, Mylan Laboratories Limited, and SST College of Pharmacy. With a strong academic background in pharmacy, Dilip has made significant contributions in regulatory affairs, academics, sales, and pharmaceutical marketing throughout their career.
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Adaptis Pharma Private Limited
Adaptis Pharma is a regulatory solutions and services company that offers end-to-end regulatory services to pharmaceutical and life sciences industries. The services include customizable and professional ANDA holding and global regulatory services to generic industries. Adaptis is established in August 2020 and headquartered at Panaji, Goa, and operational office at Pune, Maharashtra, India. Adaptis expertise in specialized regulatory strategy and fillings across all major global markets for all type of products and dosage forms. We serve emerging-to-enterprise organizations on a worldwide basis, by delivering cost effective regulatory solutions with quality. Our Mission is “To support our client's business by providing high quality services and simplified solutions.” Our Vision is “To become most trusted business partner and service provider for health care companies.” Our Service Portfolio Detailed as fallows: ANDA Holding Regulatory Intelligence Regulatory Strategy and Business Consulting End-to-End Regulatory Support for the Companies Looking for Expansion in to the Regulated and Semi-Regulated Markets Complete Support for Compilation of USDMF/APIMF/WHO- PQP/ANDA/NDA/IND/BLA/MA Modules with no RTR Assurance for ANDA Artwork and Labeling Dossier Query Response Submissions Post Approval Submissions like Prior Approval Supplement, Change Being Effected Supplement and Variation Filing for Global Market Lifecycle Management of DMF/ANDA/MA Regulatory Software (eCTD and Structured Product Labeling) R&D Regulatory Strategy and Systems Controlled Correspondence with USFDA Clinical Overview and Non-Clinical Overview US Agent Services Audit and Compliance For more information reach out us @E-mail: bd@adaptisls.com; info@adaptisls.com; Mobile: +91 9923419592 or +91 9834614269