We offer a full range of regulatory advice services, and regulatory execution services, so be it technical and strategic planning right through to document preparation we are there to help.
- Orphan Applications, EU and USA
- Marketing Authorisations, OTC,GSL,P,POM,ATMP,Device
- CTA applications including responses to objections for a large number of EU countries
- Clinical overviews and summaries – tailoring these for regulatory submissions
- Scientific advice/Protocol assistance briefing documents
- Paediatric development plans
- Sound knowledge of the Centralised procedure including life cycle maintenance (Type I and Type II variations)
- Risk minisation plans
