Pricing applications
Prepare pricing application dossiers in line with current procedural requirements.
Lifecycle Management
Product information and authorisation records require ongoing attention.
Regulatory support beyond initial approval
- Variations
- Type I and Type II variation files and other applicable change dossiers, with electronic submission support when requested.
- SmPC & Patient Leaflet
- Preparation and updating of Summary of Product Characteristics and Patient Information Leaflet (SmPC / PIL).
- Marketing Authorisation Transfers
- Dossier support for the transfer of marketing authorisations.
- Renewals
- Documentation for renewal applications and related lifecycle steps.
Access and economics
Pricing, reimbursement & pharmacoeconomics
Regulatory support connecting dossier requirements with access considerations.
Reimbursement applications
Compile and prepare reimbursement submissions and accompanying documents.
Pharmacoeconomic reports
Support preparation of pharmacoeconomic evaluation reports for reimbursement applications.
Regulatory support is tailored to the product, jurisdiction and agreed service scope.