Make your pharmaceuticals available to 200 million Europeans

Entering the European market is not easy. 44 countries with different healthcare systems. What is your strategy? Apart from the Big-5, what do you do with the other  countries? We offer a solution for 28 countries. Sales and marketing is our core business.

We know these local markets, and this gives you the best opportunity to commercialize your specialized (niche) pharmaceuticals. A single point of contact gives you the possibility to have your products available to 200 million Europeans in 28 countries. For all 28 countries or a selection of these countries.

Achieving reimbursement and getting the right price are the 2 most important drivers for a successful launch of an innovative pharmaceuticals in our part of Europe. Health Authorities in any European country decide individually based on their local regulations, policies, framework, social values and available health care budget.

Regulatory Affairs (RA): Unlike other regions, in the EU a number of options is available to obtain a marketing authorisation. Centralised at the European Medicines Agency in Amsterdam or decentralised with the individual competent authorities of the member states, each marketing authorisation application procedure has its pros and cons. We can therefore provide you with independent and optimal advice on the best suitable regulatory strategy on a case-by-case basis.

It is essential that the safety of all medicines is monitored throughout their use in healthcare practice. EU law requires each MA holder, national competent authority and EMA to operate a pharmacovigilance system. We know and worked with the right consultants whom have extensive experience in pharmacovigilance.