Important to bear in mind – also during the development phase

For your initial clinical investigations in man you need an IMPD, which – in terms of structure – is similar to the marketing authorisation dossier. Your IMPD requires regular updating. If this task is well planned and organised, your marketing authorisation dossier can develop in parallel with your IMPD.

We provide support or else assume complete responsibility for this task. This leaves you free to concentrate on the essentials of your development work, while we maintain your dossiers – from the IMPD right through to final marketing authorisation. In so doing we rely entirely on electronic document formats. We have been fully acquainted with the electronic standards for many years and are in tune with all the latest eCTD developments (human) and any other electronic formats (such as NeeS; e.g. for veterinary medicinal products).

We make sure your medicinal product dossier shapes up

The compilation of Modules 1 to 5 in the currently valid CTD format is governed by the legal provisions as well as your own individual decisions. We can advise you extensively as to which types of documentation you require under the terms of EU legislation. We are also glad to answer any queries about your marketing authorisation and product maintenance projects. Given the growing importance of electronic documents, we assist you with the preparation of your submission documents in the eCTD format.