Regulatory Strategy and Support

Regulatory Strategy and Support S.L. is a Barcelona based Regulatory Affairs services provider committed to accompany your development project (small molecules, advanced therapy medicinal products, biologics) along the regulatory pathway to success. Services based on solid expertise in defining optimised regulatory development plans in the EU and USA.

Let us assist you to define the best strategy and to get ready for your interactions with regulatory agencies (FDA, EMA, AEMPS, MHRA). Expertise in FDA (INTERACT, Pre-IND/End-of-Phase meetings, IND submissions, Orphan Drug Designation, Fast Track and Breakthrough Therapy designations) and in EU/EMA procedures (Scientific Advice, PRIME designation, Orphan Drug Designation, IMPD, Clinical Trial Application, PIP).