CTD dossier & NtA 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.
- Marketing authorisation dossiers for human medicinal products (CTD modules 1 to 5)
- Marketing authorisation dossiers for veterinary medicinal products
- Planning, preparing, updating and reformatting of quality dossiers
- Compilation of pharmacological/toxicological expert reports, clinical expert reports, environmental compatibility testing, etc.
- Communication with regulatory authorities
- Monitoring of deadlines
- Reformatting NtA > CTD and CTD > eCTD
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.
NtA – dossiers for veterinary medicinal products
Veterinary medicinal products require a dossier structure according to the Notice to Applicants (NtA) rather than the CTD format to gain marketing authorisation. Diapharm prepares and maintains this type of dossiers.