Creation and Maintenance
Diapharm provides support with:
- Medicinal product dossiers for human medicines (Modules 1 to 5)
- Planning, creation, updates, and reformatting of the quality dossier (NtA > CTD and CTD > eCTD)
- Preparation of pharmaceutical-toxicological reports, clinical assessments, environmental impact assessments, etc.
- Communication with authorities
- Deadline monitoring
- Variations
In addition to the documentation tasks for the approval dossier, Diapharm also supports pharmaceutical companies with formal requirements: Diapharm takes direct responsibility for products, for example, in the roles of Qualified Person (QP), Qualified Person for Pharmacovigilance (QPPV), or Information Officer under the German Medicines Act (AMG).
Basic structure of the dossier
The Common Technical Document (CTD) was developed by the ICH and is the standard format for the approval of human medicines in the European Union, the United States, Japan, and several other countries, including Switzerland and Canada. It consists of five modules:
- Modul 1 contains administrative information. The exact requirements vary by ICH region.
- Modul 2 includes the table of contents as well as summaries of Modules 3 to 5.
- Modul 3 contains information on pharmaceutical quality.
- Modul 4 covers non-clinical or preclinical studies to demonstrate safety.
- Modul 5 includes clinical studies to demonstrate efficacy.
The electronic form of the approval documentation, called the eCTD dossier, is content-wise identical to the CTD format. The individual chapters are stored as XML documents in a predefined folder structure and transmitted to the regulatory authority with additional information. This electronic submission of approval documents is mandatory.
Diapharm assesses existing CTD dossiers for their suitability and conducts supplementary literature searches and the processing of scientific findings.
Variations
Any change to a product parameter—whether it’s a new manufacturing site, a formulation change, or a new testing method in quality control—requires the submission of updated CTD data. For Renewals, Line Extensions, and other variations, Diapharm creates submission-ready documentation and dossiers with efficient workflows.
Dossier
For the dossier, Medical Writers prepare expert reviews for the preclinical part (CTD Modules 2.4, 2.6, 4) and the clinical part (CTD Modules 2.5, 2.7, 5).
For clinical studies, Diapharm develops the documents: Development plan, Investigational Medicinal Product Dossier (IMPD), Investigator's Brochure, final report.
As part of the approval documentation, Diapharm also prepares the necessary product information (Summary of Product Characteristics; SmPC) and the patient information leaflet (PIL), commonly referred to as the "package insert."
