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.
Our
Services
Dossier compilation:
• Writing of Risk Management
Plan (RMP)
• Writing of Environmental
Risk Assessment (ERA)
• Preparation of Product
Information (labels, leaflets and SPC)
•
User Testing of Package Leaflets
Application Management of:
• EU Mutual Recognition
procedure (MRP)
• EU Decentralised Procedure
(DCP)
• EU Centralised Procedure
(CP)
• US IND/NDA 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.
