Drug Instruction Translation with Notarization
Professional drug instruction 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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Medical Translation
Cost
1 page of drug instructions
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
Popular Languages
Pharmaceutical Leaflet Translation: SmPC, PIL, Labelling
Translation Agency "Universal" specializes in translating drug instructions for pharmaceutical companies, CRO organizations, and regulatory consultants. We translate the complete documentation set: Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and packaging labelling.
Every translation is performed by a specialist with a pharmaceutical background who knows INN (International Nonproprietary Name) terminology, MedDRA classification (for coding adverse reactions), and the ATC system (Anatomical Therapeutic Chemical classification). We work in SDL Trados and memoQ with pharmaceutical TMs and terminology databases.
Types of Pharmaceutical Leaflets
SmPC (Summary of Product Characteristics)
- Full product description for healthcare professionals
- Pharmacodynamics and pharmacokinetics
- Indications, contraindications, adverse reactions
- Posology and method of administration
- Interactions with other medicinal products
PIL (Patient Information Leaflet)
- Patient information in plain language
- Readability test compliance
- Q&A format per QRD template
- Adverse effects by frequency (MedDRA)
- Storage conditions and shelf life
Labelling
- Primary packaging text (blister, ampoule)
- Secondary packaging text (carton)
- Character count limitations
- Braille text (for the visually impaired)
- Pictograms and symbols
Other Documentation
- MSDS / SDS (Safety Data Sheet)
- Clinical pharmacology article
- Information for pharmacists
- Promotional materials for HCPs
- Educational materials (RMP)
Regulatory Standards and Requirements
Roszdravnadzor (Russia)
Leaflet structure per Ministry of Health Order No. 803н. Mandatory sections: INN, dosage form, composition, pharmacological group, ATC code, indications, contraindications, posology, adverse reactions, overdose, interactions, special precautions, shelf life, storage conditions.
EMA (European Union)
QRD (Quality Review of Documents) template for SmPC, PIL, and Labelling. Adverse reactions coded per MedDRA with frequency (very common, common, uncommon, rare, very rare). PIL undergoes Readability Test to verify text clarity for patients.
FDA (USA)
Prescribing Information (PI) format with Highlights Section. Mandatory sections: Boxed Warning (if applicable), Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions. Patient Package Insert — for OTC drugs.
Leaflet Translation Pricing
| Document Type | Price (English) |
|---|---|
| SmPC (for healthcare professionals) | from 600₽/page |
| PIL (patient leaflet) | from 600₽/page |
| Packaging labelling | from 600₽/page |
| MSDS / SDS | from 600₽/page |
1 page = 1,800 characters of translated text with spaces. Minimum order — 1500₽. We work under contract. Discounts for series of 5+ leaflets.
Send a leaflet for evaluation — we'll quote within 30 minutes. For serial orders, we create Translation Memory for terminology consistency and reduced repeat costs.
See also: Medical translation, Medical dossier 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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