YOUR PARTNER
for a full Regulatory Affairs Service

Approval Phase - including Marketing Authorisation Application

Regulatory Submission Strategy

Do you know which regulatory route(s) your product is eligible for?
We can devise a strategy that combines commercial/regulatory needs!

Document compilation

Plan for early submission by building a CTD as you move through you development programme (save 3-6 months)

No EU presence - No problem

If your company does not have EU presence we can assume the responsibilities of MA holder until you find a marketing partner.

If you are 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.

Dossier compilation and advising on regulatory procedures forms the core of our business. Our highly skilled admin support team keep costs down and gets projects completed on time and within budget.