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


Health Care

Life Sciences

Pharmaceutical

Adaptis Pharma Private Limited

Adaptis Pharma Private Limited's headquarters in Pune, India

Description

People (1)

Dilip Shivale

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