Real Regulatory has vast experience with supporting SME innovators to navigate the national interpretations of the European medicines legislation and procedures.
We are actively advising numerous SME clients on European regulatory strategy or working as their virtual European regulatory affairs department. Indeed, we also provide business support in providing Real Regulatory (as an established EU and UK company entity) as a bridge for those companies that do not yet have an established company entity within Europe. In order to avail of fee incentives and to get the support of the EMA, this is mandatory. It is possible to annex non-EU companies on Real Regulatory’s SME status with EMA. It is possible for Real Regulatory to act as your sponsor for your EU Orphan Designation.
Real Regulatory can:
- Annex non-EU companies on our existing SME status to avail of up to 90% fee reductions on EMA Scientific Advice, GxP inspections and scientific services, and deferral of the EMA MAA fee until the end of the Centralised Procedure
- Act as your sponsor for EU Orphan Designations
- Act as your European regulatory team
- Help you to navigate European National and EU regulatory processes
- Bring all of the other expertise described elsewhere to supplement your internal team knowledge of the product