We carry out the maintenance of marketing authorisation documents with the correct combination of accuracy and efficiency. Our regulatory affairs specialists provide advice, prepare dossiers and keep them up-to-date at all times.
We take over every aspect of maintaining and (re)formatting of existing documentation in eCTD or CTD format as needed.
In addition to taking on the tasks related to the documentation for your dossier, Diapharm also offers support when it comes to the formal requirements imposed on pharmaceutical companies. On request, we will take direct responsibility for your product – for example, by taking over functions in accordance with EU Directive 2001/83/EC as qualified persons (QP), qualified persons responsible for pharmacovigilance (QPPV), information officers.
The common technical document (CTD) was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It is the standard format used to gain marketing authorisation for human medicinal products in the European Union, the US, Japan and many other countries, including Switzerland and Canada. It consists of five modules:
The electronic form of this marketing authorisation document, known as an eCTD, contains the same information found in a regular CTD. The individual modules are saved as XML documents in a specific file structure. Supplementary information is then added, and the entire documentation is transmitted to the appropriate regulatory authority. Electronic submission of marketing authorisation documents is set to become compulsory in the near future.
On behalf of our clients, we can evaluate how well-suited existing CTD dossiers are for the marketing authorisation process and for special instances, such as well-established use (WEU) authorisation. We also can provide thorough literature research for our clients and process scientific findings to enable their use in dossiers.
Our medical writers draft expert reports on the pre-clinical (CTD modules 2.4, 2.6, 4) and clinical (CTD modules 2.5, 2.7, 5) sections of marketing authorisation dossiers. We review the study data provided by the client and conduct full literature research if necessary. We also process deficiency letters from the authorities during the marketing authorisation process.
Any change in a product parameter - be it a different manufacturing site, a recipe change or a new test procedure in quality control - requires the resubmission of updated CTD data. In the case of renewals, line extensions and other variations, we use efficient workflows to create appropriately adapted, submission-ready documentation and dossiers.
For clinical trials, we develop the documents: development plan, Investigational Medicinal Product Dossier (IMPD), Investigator's Brochure, final report, etc. We are also active for our clients in clinical trials after (initial) approval. As part of the marketing authorisation documentation, the medical writing team also prepares the necessary Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL), colloquially known as "package leaflet". As the information officer, we also assume responsibility for these and other documents on request.
