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Approval/Registration Phase - including Marketing Authorisation Application

Regulatory Submission Strategy

Do you know which regulatory submission route(s) your product is eligible for?
Do you know which countries you want to access first?
Can you get the indications you want in your countries of choice?

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. Better still, build an eCTD dossier. Early use of this invaluable tool in product life cycle management will undoubtedly prove to be good long term money and time saving investment.

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...)