Marketing authorisation procedures

The right procedure for your product

Under European legislation you have various possibilities when applying for the marketing authorisation of a medicinal product. For many years we have worked continuously with a large number of internationally active companies with widely differing product portfolios and objectives. Consequently, we are fully acquainted with all types of procedure (centralised, decentralised, national). We are aware of the regulatory and content-related possibilities and limitations. Last but not least, we are familiar with the authorities and their interpretations of the regulatory requirements - for medicinal products for human and for veterinary use.

Thanks to more than 15 years of experience in regulatory affairs, we are ideally equipped to recommend the marketing authorisation procedure that is best suited to your strategic objectives.