Advice on the US Food and Drug Administration and/or the European Agency for the Evaluation of Medicinal Products Regulations

We can guide your clinical development program through the myriad regulations of the US FDA and/or the EMEA. We have experience in writing INDs and CTAs, preparing briefing packages and preparing for and attending meetings with the FDA and EMEA through to preparation of the clinical sections of the Common Technical Document.

If you are developing a product in an orphan indication our experienced team can prepare orphan drug designation applications for the FDA and EMEA.