Market Access is an essential step in the process of Pricing and Reimbursement of novel medicinal products throughout their life cycle. It evolves within the technical and administrative framework of procedures and requirements laid by national jurisdictions.
At CEMKA, the Market Access team is made up of a range of consultants with a broad experience in the pharmaceutical industry in Pricing and Reimbursement, Regulatory Affairs, Market Research, Pharmacovigilance and Clinical Research. Adaptability, complementarity and team spirit ensure the excellent management of the projects:
- Strategic guidance in Pricing and Reimbursement (products in development or already marketed)
- Clinical and Pricing dossiers, Early access
- Support in interactions with local authorities (early dialogues, pre-submission meetings, hearing)
- Assistance in other dossiers: Hospital drugs and devices specific funding, retrocession, early access programs, fast-track evaluation etc.
- Post-submission support including response to formal evaluation reports and appraisal meetings
- Literature review, evidence research, test and discussions with local experts to generate product value messages
- Long-term support
- Training in Pricing and Reimbursement issues
- Continuing exchanges with companies to ensure strategic coherence
- Relevance of argumentation
- Writing skills in substance and form
- Forceful proposals/creativity
- Convergence of the expectations of Pharmaceutical Companies and the Authorities