Medical Dossier Translation with Notarization
Professional medical dossier translation from 600₽ per page + notarization 1000₽. Ready in 1-2 business days. In-house notary near metro. Accepted by all government agencies, courts, and embassies.
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Cost
1 page of medical dossiers
Per document
Advantages
- Translators with 5+ years of specialized experience
- In-house notary — certification in 2-4 hours
- Accepted by all government agencies and embassies
- Free courier delivery within Moscow Ring Road
- CAT tools for terminology consistency
- Official contract, closing documents for legal entities
- Free courier delivery in Moscow
What Medical Dossier Translation Includes
A registration dossier (CTD — Common Technical Document) is the primary document for drug registration in any country. The format is standardized by ICH and includes five modules. We translate each one according to the target regulatory authority's requirements.
- Module 1 — regional administrative information: statements, GMP certificates, labelling, patient information leaflet (PIL)
- Module 2 — overall summaries on quality, nonclinical and clinical data (QOS, Nonclinical Overview, Clinical Overview)
- Module 3 — quality data: drug substance (3.2.S), drug product (3.2.P), method validation, stability
- Module 4 — nonclinical reports: pharmacology, toxicology, animal pharmacokinetics
- Module 5 — clinical studies: protocols, clinical study reports, statistical analysis, PSUR
Terminological Accuracy
A dossier contains thousands of specialized terms: INN (International Nonproprietary Name), ATC classification, pharmacopoeial methods (USP, EP, JP), GMP terminology. We use terminology databases in SDL Trados and memoQ to ensure the same term is translated consistently across all 5 modules. Translation memory (TM) accumulates from project to project, reducing costs for repeat orders.
Regulatory Authorities We Translate For
Roszdravnadzor / Ministry of Health (Russia)
Translation from English to Russian for registration in Russia. EAEU requirements, national dossier format.
EMA (Europe)
Translation into English, German, French. eCTD format. Directive 2001/83/EC requirements.
FDA (USA)
Translation into English. ANDA, BLA submissions. 21 CFR requirements.
PMDA (Japan)
Translation into Japanese. J-CTD format. Specific MHW requirements.
Pricing and Turnaround
Base rate — from 600₽ per translated page (1,800 characters). Volume discounts: 50+ pages — 3%, 100+ pages — 7%, 150+ pages — 10%. Rush translation (×1.5 coefficient) available subject to team availability. Typical turnaround: Module 1 (50–100 pp.) — 1 week, full dossier (1,000+ pp.) — 1–2 months.
Confidentiality
Translators work in a secure environment. Files are transferred via encrypted channels. Data on drug composition, clinical trial results, and manufacturing processes never leaves the project team.
See also: medical translation, pharmaceutical leaflet translation, SOP translation.
Calculate Translation Cost
Get the exact price for your order in 30 seconds
1 page = 1,800 characters with spaces
Character count is based on the translated text. For a more accurate quote, please submit a request.
A manager will respond within 30 minutes.
How We Work
Submit Your Request
Fill out the form on our website, call us, or send a message. Attach documents for a quote.
Get a Quote
Our manager will calculate the exact cost and timeline within 30 minutes. No hidden fees.
We Translate
A specialist translator does the work. An editor reviews quality. A notary certifies (if needed).
Receive Your Translation
Free courier delivery in Moscow or email delivery. Payment upon receipt.
For Business Clients
We work with companies of any scale — from startups to corporations. Official contract, full document workflow, dedicated manager.
Contract & NDA
Official translation services agreement. NDA to protect trade secrets.
Bank Transfer Payment
Wire transfer, deferred payment for regular clients. VAT-exempt.
Closing Documents
Completion certificate, invoice — full package for your accounting department.
Volume Discounts 3–10%
50+ pages — 3% off. 100+ pages — 5%. 300+ pages — up to 10%.
Dedicated Manager
Single point of contact for all projects. Timeline, quality, and budget control.
CAT Tools, Save up to 40%
SDL Trados, memoQ — translation memory reduces cost of repetitive content.
FAQ
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