Professional eCTD dossier compilation using the "Dossier Composer" system.
We offer services for the preparation and technical support of drug registration dossiers in eCTD format (in accordance with current EAEU requirements and Decision No. 114). To ensure maximum precision and efficiency, we utilize Dossier Composer—our proprietary, high-tech solution that automates the most critical stages of document assembly.
Our system automatically recognizes and distributes files across CTD (Common Technical Document) sections using semantic analysis and section code detection in filenames, eliminating human error risks associated with manual sorting of thousands of pages.
The system’s section tree fully complies with the latest regulatory requirements (including Modules 1–5), ensuring the correct registration of complex entities such as Site Master Files and clinical study reports.
The software automatically generates the XML package structure (index.xml and util.xml), embedding the required metadata, hyperlinks, and checksums (MD5 hashes) for every file; every dossier we assemble undergoes automated pre-validation for compliance with EEC XSD schemas prior to regulatory submission.
We ensure precise management of sequences and Unique Universal Identifiers (UUIDs), which is critical for future dossier amendments without Lifecycle Management errors.
The "Dossier Composer" software suite is an internal tool used exclusively by our company; we do not distribute the application to third parties, thereby guaranteeing data confidentiality and the exclusive quality of the final product prepared by our specialists.
Our solutions ensure the protection of trade secrets through rigorous internal protocols; all dossier assembly operations are logged to eliminate unauthorized access risks when handling sensitive data, while the use of our proprietary "Dossier Composer" software guarantees that your intellectual property remains under secure control without being transferred to third-party services.
