Successful market access makes the value of innovative and meaningful products available to patients. DADA has the people and the network to support you with that.
When Regulatory Affairs is involved in early stages of Market Access, the pre- and post-authorisation activities will align more effectively and provide better value to patients, faster. Our Regulatory Affairs experts know what to do. Go to our Regulatory Affairs services to see how we support your business.
The innovative and meaningful properties of a product are known well before the product obtains marketing authorisation. It is in the interest of patients to have access to any valuable product property as soon as possible. Early Access to medicine are tools that allow such access. We are more than happy to assist in planning and applying for Early Access Program authorisations. Go to our Early Access programs page to see what DADA can do for you.
Pricing and Reimbursement
Pricing and reimbursement are expert processes. A market access scan is the start. The insights gained from the scan benefit your strategy and timing. They provide excellent Pricing and Reimbursement dossiers, focused Stakeholder management and Health System readiness. DADA knows the best experts, and links your demands to the right experts in the BeNeLux.
The EU market is characterised by high population densities, shared languages, and harmonised regulations. Those circumstances allow meaningful supply chain efficiency gains though the consolidation of package designs for multiple EU member states. In other words: distribution of a single pack design to multiple countries. It is easy if you know the way. DADA does.
The Falsified Medicine Directive (FMD) requires tamper evidence on the pack and full traceability across the supply chain of prescription medicine. FMD is mandatory across EU member states since 2019. Individual member states may have individual demands, therefore it is necessary to comply with FMD on both EU and EU member state level. The traceability part takes time, effort, and IT to get right, and a natural part of commercializing your PO medicine.
Ultimately, packs must be produced in line with these regulations. This process requires thorough planning and management. Not only in terms of package designs and FMD requirements: once approved, regulatory life cycle management is mandatory to maintain a product dossier. DADA knows how to use life cycle management for the benefit of production. Just reach out to us to understand how.