Access global & Indian regulatory pathways with confidence. We deliver end-to-end support for CDSCO (India), US FDA (510(k), IDE, De Novo, PMA), CE marking under EU MDR/IVDR, TGA Australia, Health Canada, UKCA, SFDA (Saudi Arabia), MDA (Malaysia), HSA (Singapore), COFEPRIS (Mexico), ANVISA (Brazil). From dossier preparation, technical documentation, notified/authorised body coordination, to post-market compliance- we guide you through global regulatory strategy, submission, approval and maintenance.
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