Emering Markets

Using existing dossiers

In many cases the marketing authorisation requirements in Emerging Markets are still relatively "moderate". Frequently, these requirements can be fulfilled using existing documentations compiled for submission within Europe (i.e. the documentation is already at your disposal). As a result a relatively low level of investment is required in order to develop business opportunities in these Emerging Markets. Your local branches and distribution partners have an interest in exploiting your existing marketing authorisations. With relatively little effort you will be in a position to respond to the requirements and wishes of your local branches and customers.

We will revise your existing documentation in line with your specific requirements – either as a complete dossier or lean dossier. In addition, we can provide the necessary translations. In this context the multilingual skills of our team prove very helpful. Frequently, it is possible to conduct negotiations with the local regulatory authorities and branches in the national language, which leads to greater effectiveness.

Our services:

Compilation of the marketing authorisation in accordance with national requirements:

• Procurement of legal documents, e.g. CPPs, LoAs, Poders, LoDs
• Implementation of legalisation processes, e.g. for manufacturing authorisations, GMP certificates
• Creation of country-specific texts and documents, e.g. labelling, PL, SmPC
• Creation of other country-specific texts
• Processing of all national applications
• Coordination and supply of samples, substance samples, CoAs
• Mailing of material to countries in all continents
• Electronic processing in accordance with current requirements (eCTD, NeeS, ASEAN eCTD)