YOUR PARTNER
for a full Regulatory Affairs Service

Approval/Registration Phase - including Marketing Authorisation Application (MAA)

Regulatory Submission Strategy
Do you know which regulatory route(s) your product is eligible for?
Which countries do you want to access first?
We can devise a strategy that combines commercial and regulatory needs.

Dossier compilation
Plan for early submission by building a CTD as you move through your development programme reducing time to market by months.

No EU presence? No problem!

If your company does not have an EU presence we can assume the responsibilities of the MA holder until you find a marketing partner. (read more here...)

Are you seeking EU-wide registration and don't have presence in all EU member states?

We can manage any procedure through our network of regulatory associates. (read more here...)