Regulatory Compliance and Dossiers

Our in-house highly skilled Regulatory team, which also is backed by our robust quality assurance and analytical departments ensures smooth submission of international standard dossiers as per eCTD/ACTD and ICH guidelines to the respective MOH within timelines. What makes Onemedic a perfect supplier is, unlike most of the companies who fail to provide the critical documents in dossiers like BE studies and Raw data, we Onemedic team is fully equipped to ensure all critical elements of the dossiers. We have tie ups with internationally accredited clinical labs to perform provide the Bioequivalence (BE) studies for our products which empowers our distributors team to submit the complete documentation and dossiers as per CTD guidelines.