Quick and efficient

Profit from our experience with marketing authorisation procedures throughout the EU, EFTA (i.e. including Iceland, Norway, Liechtenstein) and Switzerland. Also for countries outside Europe (Emerging Markets) you can make use of our expertise. We guide your dossiers smoothly through the approval process and make sure that your products achieve marketing authorisation as rapidly as possible.

Competent and reliable

CP, DCP or MRP? We are also very well versed in the specific national authorisation, variation and renewal procedures. Do you want to develop new markets for your existing products? If so, our partner network and our own branch offices will put you on the right track.

Our services for you:

• Strategic planning of your marketing authorisation procedures
• Submission of dossiers
• Process management
• Support up to and including the granting of marketing authorisation in the entire European Economic Area
• Support up to and including the granting of marketing authorisation in regions outside Europe (Emerging Markets)
  
• Interfacing with the various competent regulatory authorities

Complete lifecycle management: e.g. variations, renewals, follow-up of conditional authorisations, preparation and submission of PSURs, etc.