TMC works extensively with sponsors throughout the USA, and we offer services designed to help our American and other ex-EU clients achieve better access to European markets.
The European pharmaceutical market is even larger than that of the USA, with over 503 million inhabitants in the 28 EU countries alone, compared to 326 million in the USA (figures from 2015). And, with new countries joining the EU, this is a rapidly expanding market. If your organisation does not yet have an office in Europe, now may be the time to create one.
Procedures for obtaining marketing approval throughout all countries in the European Union mean that eligible products can be submitted as just one marketing authorisation application, made centrally, for all member states.
Any pharmaceutical or biotech company with innovative products should have direct access to the European market place. To hold an EU market licence, you must have either an EU-based partner or an affiliate company in the EU.
TMC can set up a European operation of any size, with scope for any level of activity. We can:
- Create a company in your name with care-taking, contact and mailing possibilities
- Provide use when needed of TMC’s facilities and experienced scientific and administrative staff to run a 'virtual' organisation
- Implement a full start-up company, from location of offices and recruitment of staff through to initiation of development activities and sales
- Act as your legal representative in the EU - a prerequisite for clinical trial applications
- Act as your EU company sponsor, as required for orphan drug designation or marketing application
- Hold and manage Marketing Authorisation licences on your behalf