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.
Our
Services include:
• Writing a Risk Management Plan (RMP)
• Writing an Environmental Risk Assessment (ERA)
• Preparation of Product
Information (labels, leaflets, and SPC)
•
User Testing of Package Leaflets
• EU Mutual Recognition Procedure (MRP) Management
• EU Decentralised Procedure Management
• EU Centralised Procedure Management
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.
