Approval/Registration 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!
Dossier compilation
Plan for early submission by building a CTD as you move through
your development programme reducing time to market by months.
Our
Services:
Dossier compilation
• Writing of Risk Management Plan (RMP)
• Writing of Environmental Risk Assessment (ERA)
• Preparation of Product
Information; labels, leaflets, and SPC
Application Management of:
• EU Mutual Recognition Procedure (MRP)
• EU Decentralised Procedure (DCP)
• EU Centralised Procedure (CP)
• US IND/BLA procedures
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...)
Dossier compilation
and advising on regulatory procedures form the core of our
business. Our highly skilled admin team helps to keep costs
down and projects moving.
