Pharmaceutical and medical translator based in Berlin, working in English, German, and Russian. Over a decade of experience with regulatory dossiers, clinical documentation, and GMP materials for pharmaceutical companies, CROs, and regulatory consultancies worldwide.

Core expertise:

• Pharmaceutical and regulatory: CTD dossiers, SmPCs, Module 1–5 submissions, correspondence with authorities
• GMP documentation: manufacturing records, SOPs, validation reports, CEPs, audit materials
• Clinical and scientific: study protocols, informed consent forms, investigator's brochures, pharmacovigilance reports (PSUR, PBRER, DSUR)

• Contracts and service agreements in the pharmaceutical sector

Certified (sworn) translator for Russian, appointed by the Berlin Regional Court (Landgericht Berlin). Diplom-Übersetzer. 

Member of the BDÜ (German Federal Association of Interpreters and Translators).

Language directions:

• German ↔ Russian (certified translations available in this pair only)
• English ↔ Russian
• French → Russian/German (for selected projects)

Certified translations of civil-status documents, diplomas, and corporate records for German authorities, courts, and universities.

Also handle related technical and legal fields: chemistry, medical devices, contracts, and patent documentation.

Tools: Trados Studio 2024, memoQ, Weblate. 

NDA/CDA signed on request.

For further information or to discuss a project, please contact: dmitri.mikhalitsyn @ 2translators.net