Adaptis Pharma Private Limited

Adaptis is a trusted provider of pharmacovigilance and regulatory solutions for the pharmaceutical and life sciences industries. Established in August 2020, we are headquartered in Panaji, Goa, with an operational office in Pune, Maharashtra, India. Our focus is on delivering global pharmacovigilance, regulatory affairs, and ANDA parking services with an emphasis on compliance, quality, and cost efficiency. Our Mission: To support clients by providing high-quality solutions and simplified solutions. Our Vision: To become the most trusted partner for healthcare companies worldwide. What We Offer: Pharmacovigilance Solutions: Individual Case Safety Report (ICSR) Medical Information Call Centre (MICC) Aggregate Reports Literature Monitoring Pharmacovigilance Site Master File (PSMF) Risk Management (RMP/REMS) Signal Management Safety Data Exchange Agreements (SDEA) Qualified Person for Pharmacovigilance (QPPV) Regulatory Affairs Solutions: Regulatory Operations Excellence Regulatory Document Design Regulatory Intelligence & Strategy Medical Writing Lifecycle Management (DMF/ANDA/MA/ANDS) Artwork & Labeling Dossier Query Response Submissions Dossier Due Diligence ANDA Parking & MA Holding Solutions: Customizable ANDA parking solutions MA holding services for generic industries Expertise in ANDA submission, review, and variation filing We combine pharmacovigilance expertise, regulatory knowledge, and ANDA solutions to ensure compliance and help clients navigate complex global markets efficiently. Email: bd@adaptisls.com | info@adaptisls.com Phone:+91 9923419592 |+91 9834614269