Translations

Vialtech specializes in translation of pharmaceutical documents:

complying with best practices (GXP);
related to the development of preclinical and clinical trials of pharmaceuticals;
related to the examination and state registration of pharmaceuticals including medical registration dossier documents;
necessary for inclusion in the GRLS registry of pharmaceutical substances;
related to the registration of medical devices, including examinations of the quality, effectiveness, and safety of medical devices, and their corresponding registration dossiers;
linked to various stages of drug manufacturing:
- licenses for the type of activity performed
- GMP certificates
- ISO certificates
- quality manuals and policies
- standard operating procedures [SOPs]
- product quality reviews [PQRs]
- risk analysis reports
- reports on monitoring
- reports on stability studies
- dossiers for a series of products
- documents on qualifications of systems and equipment
- documents on validation of production processes
- validation, verification and transfer of analytical methods
- quality control documents [analytical dossiers, protocol analyses, quality certifications]
- claim documents regarding product recalls from the Russian market
- audit reports and other documents
for dietary supplements;
for chemical, medical and biopharmaceutical profiles.