Our wealth of experience is the difference that enables us to support the introduction of so many new products to market.
Our wealth of experience is the difference that enables us to support the introduction of so many new products to market.
Market Access
Our knowledge and understanding stretches across all geographies can be executed on a EU wide basis or
- Advice and assistance for compliance with the local requirements
- Assistance in early access programs (ie. compassionate use)
- Liaison with the regulatory authorities
- Assist in developing, assembling, reviewing clients’ meeting request package and initiate contact with agencies. Attend meetings with authorities
- Facilitation of local concerns via a network of partners in EU countries and USA
- Consolidated network of partners in EU countries and a local Agent in the USA allow us to support our clients facing specific local issues.
Pricing and Reimbursement
Pricing and reimbursement of medicinal products is not harmonised on a European level but belongs to the exclusive competence of the EU Member States. As a result, there are different statutory health schemes within each European country and the pricing and reimbursement of pharmaceuticals. Assion is able to support you by:
- Preparation of national Pricing & Reimbursement applications
- Negotiation with the authorities
- Coordination of Pricing & Reimbursement applications in EU countries
On demand regulatory team an Assion case study
A small-to-medium sized biotech business faced challenges right sizing and staffing an international regulatory organisation. Our client was entering new markets and as such required a significant amount of support in the pre-launch and launch years of commercialization. However, once that work was completed, the required activities would significantly reduce.