The regulatory affairs team at Sciformix will help you develop your registration strategy and help you in submissions management (authoring, compilation and publishing the dossier).

The team provides all the support you need to meet internal and regulatory agency timelines and the credibility to face regulatory scrutiny, thus increasing the chance of approval.

We also provide support after product approval, through the entire lifecycle, including authoring amendments, variations, annual reports, deficiency responses and regulatory audit responses.