CTD dossier preparation

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.


Our services

  • Marketing authorisation dossiers for human medicinal products (CTD modules 1 to 5)
  • Planning, preparing, updating and reformatting of quality dossiers (NtA > CTD and CTD > eCTD)
  • Compilation of pharmacological/toxicological expert reports, clinical expert reports, environmental compatibility testing, etc.
  • Communication with regulatory authorities
  • Monitoring of deadlines
  • Variations

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.


Basic CTD dossier structure

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:

  • Module 1 contains administrative information. The exact requirements differ depending on the ICH region.
  • Module 2 contains the table of contents and summaries of modules 3 to 5.
  • Module 3 contains information about pharmaceutical quality (quality dossier).
  • Module 4 covers non-clinical and pre-clinical study reports to support safety claims.
  • Module 5 covers clinical study reports to support efficacy claims.

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. 


Audit of existing documents

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.

CTD-Dossier for marketing authorisation

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.

Variations

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.

Medical writing for clinical studies, expert information and product information leaflets

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.

  

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