About Us

Dilip started his journey in August 2020, driven by a vision to establish Adaptis as a globally recognized brand in the healthcare industry. Dilip is a seasoned regulatory, pharmacovigilance and quality assurance professional with an extensive work experience in the pharmaceutical industry for more than 20+ years. He has experience in handling more than 180 regulatory filings, including ANDA, NDA, IND, MA, and ANDS submissions, many of which include first-to-file, NCE-1 ANDA, and 505(b)(2) applications. His extensive regulatory and pharmacovigilance expertise spans the full range of dosage forms such as solid orals, liquid orals, injectables, ophthalmic, soft gels, peptides, biologics, lozenges, and gums and encompasses the original US DMF, ANDA/NDA (USA), ANDS (Canada), WHO Product Qualification, and APIMF/MA (Europe/UK) submissions, amendments, supplements, and eCTD filings.
 
Dilip has extensive experience in pharmacovigilance, including key safety and compliance solutions such as case processing, literature monitoring, and managing medical information call center. He has also handled aggregate reports (e.g., PSUR/DSUR/PBRER/PADER), RMPs, QPPV support, SDEAs, and labeling management
His deep understanding of the regulatory and pharmacovigilance landscape has enabled him to establish Pharmacovigilance, regulatory affairs and corporate quality assurance departments from the ground up for new organizations, guiding them through the product development stages to successful dossier (ANDA/ANDS/MA) approvals and end-to-end pharmacovigilance operations set-up. 
 
Dilip has held leadership roles in multinational, mid-sized, and small companies, as well as healthcare solutions providers, where he led cross-functional teams to achieve success. His professional journey includes working with renowned organizations such as VIATRIS (Mylan), Aurobindo Pharma, Unichem Labs, Graviti Pharma and Pharmazone.

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Pramod Choudhari is a seasoned analytical, regulatory and pharmacovigilance professional with over 20+ years of experience in the pharmaceutical industry. His expertise spans analytical method development, validation, and technology transfer for drug substances, drug products, and new chemical entities. Pramod has in-depth knowledge and a strong understanding of quality systems, as well as , GLP, FDA, ICH, and 21 CFR Part 11 regulations.
 
Pramod brings extensive experience managing all pre- and post-approval regulatory and pharmacovigilance compliance requirements for both pending and approved dossiers across the USA, EU, UK, and Canada.    ;              
Before Adaptis, Pramod worked with leading pharmaceutical companies like Lupin Limited, Emcure Pharmaceutical Ltd., Hikal Limited and Megafine Pharma Pvt Ltd etc.
 
With a successful track record in leading diverse pharmacovigilance and regulatory projects, Pramod has consistently delivered high-quality results to clients. His expertise in team leadership, operational management, and business development has greatly enriched Adaptis, where he currently oversees operational excellence and ensures smooth project execution.

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