Our combined experience allows us to develop a regulatory strategy from early development up to regulatory submission.
Our regulatory experts will assist you in developing your regulatory strategy and guide you through the various regulatory opportunities available for your compound (e.g. Orphan Drug Designation Application, Pediatric Investigational Plan (PIP) or waiver, PRIME eligibility).
Drafting and coordination of your regulatory strategy plan, sharing advice on regulatory deliverables and timelines, and facilitating Health Authority interactions (both in EU and US) are all crucial elements that we excel in.
We invite you to contact our experts for an initial conversation to discuss which strategy would suit your development.