Regulatory Submissions

Global Regulatory Submissions

 510(k) and PMA submissions: Our team of experts provide end to end support in preparing a comprehensive 510(k) submission, including the development of a regulatory strategy, compilation of technical information, and preparation of all necessary documentation, finalization of the submission package and electronic submission to FDA. The support also includes collation of queries from FDA and technical support for compilation and submission of responses till the final approval from FDA

CE technical file preparation: We provide end to end support to compile all the necessary information for a CE technical file, including technical specifications, risk assessments, and clinical data. The team has extensive experience with the European regulatory landscape, can help organizations navigate the complex requirements of the CE marking process.

Other Global market Regulatory Submissions: We have strong experience in the LATAM, ASEAN, APAC, MENA, CIS countries with a good understanding of the local regulatory requirements for medical devices. We provide support for compilation of technical documentations and regulatory package for submission to each Health authority, support for query response and interaction with agencies till final approval.