Scientific advice can be requested from the European Medicines Agency (EMEA) irrespective of the medicinal product’s eligibility for the centralised procedure. 

Typical reasons for using the scientific advice service include:

• If there are doubts regarding quality, non-clinical, clinical or pharmacovigilance aspects during product development
• If there is uncertainty about interpretation and applicability of certain European regulations and guidelines
• If a very innovative or borderline product is being developed, and there is a need to understand how it will be treated by the relevant regulatory agency

We can help prepare a scientific advice request and either assist in communications with the EMEA or act on your behalf.