Product Launch Support
We provide regulatory affairs services linked to the product launch activities on country-level across EU/EEA members states. We can help you execute effective medicinal product launch strategies and achieve compliance with EU/EEA and local regulatory requirements. Our thorough understanding of complex regulatory frameworks and national regulatory bodies will help you navigate the route to success.
We can help you plan the launch of your product, advice on the expected timelines, as well as anticipate potential pitfalls and risks that might cause delays. Our expertise will help you achieve optimal success in bringing your product to market and patients.
If you are planning a your product launch in the EU, you may also find our blog article about the EU Medicinal Product Launch Considerations worth reading.
Consultancy on local regulatory requirements for product launch
Labelling exemptions to supply product in foreign packaging
Educational Materials adaptation to local requirements and approval with national authority
Artwork review and approval, including ‘blue-box’ requirements and additional information
Consultancy on shared pack requirements
Pricing application and local price approval