We provide countries/Health authority specific regulatory strategy to the customers for filing their drug product in the intended market at the initial phases of submission strategy to fulfil the development and submission requirement regulatory pathways throughout the product lifecycle, addressing compliance challenges, or optimizing approvals. We handle all aspects of dossier filing, from preparation to submission. Our Regulatory CMC, Labelling and Clinical SMEs compile all required documentation in CTD, eCTD, ACTD and country specific format’s, ensuring accuracy, completeness, and compliance with global health authorities regulatory requirements. Whether it’s for ANDA, NDA, 505(b)(2), IND, ANDS, NDS, MAA, DMF, CEP, ASMF and 510(k) for new product approvals, variations, renewals, or supplements, we ensure your dossier is well-prepared and optimized for fast track and first cycle approval.

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