Emerging Markets

Experience is what counts

On the basis of its many years of experience in the pharmaceutical industry our Karlsruhe‑based team is familiar with the essentials of a successful marketing authorisation. This applies to the country-specific adaptation of documents, as well as to the modes of communication the local regulatory authorities. You can capitalise on this knowledge. We have acquired experience with marketing authorisations

• in a wide variety of countries
• across a broad product spectrum
• in all continents

Time to market plays a vital role

You decide whether to submit a complete dossier or a lean dossier in the country in question. We will advise you about which approach to adopt. The decisive factor is the total duration marketing authorisation process. A well-planned dossier resulting in only minimal subsequent queries saves valuable time – and is clearly preferable to an ill-conceived concept necessitating lengthy "error correction phases".

 What we have to offer:

• Strategic planning of your marketing authorisation projects
• Submission of dossiers
• Process management
• Support up to and including the granting of marketing authorisation
• Interfacing with the competent regulatory authorities
• Expert reports and opinions (in collaboration with your in-house departments on a case-by-case basis)
• Complete lifecycle management in relation to variations, renewal, compliance, etc.

Text modifications

In many countries product information texts for patients and medical professionals have to be submitted in the national languages and in formats which differ significantly from those used in the EU. In this context it is essential to rule out any untenable deviations in the core information relating to the product (e.g. CCDS).

Our team is ideally qualified to write and check high-quality country-specific texts. In so doing we can draw on many years of experience in export departments within the pharmaceutical industry, backed up by the extensive language skills of our staff.