Translation of Pharmaceutical Documentation and Drug Leaflets

TARGMANEBI offers pharmaceutical companies, importers, distributors and pharmacy chains the translation of pharmaceutical documentation into Georgian from English, German, Russian, Turkish, French, Italian and other languages. A non-disclosure agreement (NDA) is signed before work begins.

Who this service is for

• Importers and distributors - to prepare the registration package and the Georgian-language leaflet before a new product is brought onto the market;
• Marketing authorisation holders and their representative offices - to update a leaflet when a new indication or new safety information is added;
• Pharmacy chains - for product descriptions, training materials for pharmacists and online catalogues;
• Medical representative offices - for scientific and training materials intended for doctors;
• Manufacturers of dietary supplements and cosmetics - to translate the composition, directions for use and warnings.

In each of these cases the text has two readers: the specialist who assesses the document, and the patient or doctor who will use the product. The translation has to be equally accurate and clear for both of them.

What we translate

The structure of a leaflet: where the risks are

A drug leaflet is a document with a strict structure, and every section carries its own risk:

• Composition - the active substance under its International Nonproprietary Name (INN), the amount per tablet or per millilitre, and the excipients. Lactose, sucrose or sodium require a separate precautionary statement;
• Dosage - age groups, dose adjustment in renal or hepatic impairment, mg/kg calculations. The unit and the figure are carried over unchanged;
• Contraindications and precautions - "must not be used" and "use with caution" must never be confused;
• Adverse reactions - frequency categories under the MedDRA convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). Changing the category changes how the risk is perceived;
• Interactions - with other medicines, food and alcohol;
• Pregnancy, breastfeeding, driving - short but legally important sections;
• Storage conditions and shelf life - temperature, light, and the period of use after opening.

Packaging and labels: little space, maximum accuracy

Packaging text is much shorter than a leaflet, but the cost of a mistake there is higher: the patient and the pharmacist read the box first. The secondary packaging usually carries:

• the trade name of the product, the active substance (INN), the strength and the pharmaceutical form;
• the composition per dose and the relevant excipients;
• the route and method of administration, and the quantity in the pack;
• storage conditions, the batch number and the expiry date;
• the dispensing status - prescription-only or over the counter;
• the names of the manufacturer and of the marketing authorisation holder.

Space on the artwork is limited, so the Georgian text has to fit in a short form without losing any of its content. The packaging text repeats the terms of the leaflet exactly: if the leaflet says "film-coated tablet", the box uses the same form of words.

Pharmacovigilance: speed and accuracy together

An adverse event report is subject to strict deadlines, so its translation must not become the cause of a delay. At the same time, it is precisely these documents that contain the most details that must not be lost: the description of the event, the onset date, the seriousness, the outcome, concomitant medications and the causality assessment.

We translate such documents the same or the next day, with MedDRA terminology and a check by an editor. Free text written by a doctor or a patient - "my hand went red and itchy" - is translated exactly as it was written, without turning it into a medical term: coding is the job of the pharmacovigilance specialist.

Consistent terminology

In a pharmaceutical portfolio, the same term recurs in dozens of documents. If "hypersensitivity" is translated as "hypersensitivity" in one leaflet and as "allergy" in another, the regulator and the doctor see this as an inconsistency. That is why:

• for each client we build a term base (glossary), which is agreed with the client;
• we use translation memory, so that recurring phrases - standard warnings, storage conditions - are translated the same way in every document;
• when a leaflet is updated, we translate only the changed sections and provide a comparison file (track changes);
• leaflets for different forms of the same active substance (tablet, suspension, solution for injection) are compared with each other so that the shared sections are identical.

The general rules for terms - INN, doses, units, Latin abbreviations - are described on the page medical translation.

What the editor checks

For pharmaceutical translation, the editing stage is mandatory and follows a specific checklist. A second specialist compares the translation with the original section by section:

• every dose, unit and figure - mg, mcg, ml, IU, mg/kg, mg/m²;
• the frequency categories of adverse reactions and their thresholds;
• the completeness of contraindications and warnings - not a single item may be left out;
• the spelling of INNs and trade names throughout the document;
• section numbering and cross-references ("see section 4.4");
• consistency with the term base.

If we find an inconsistency in the original - for example, the dose in section 4.2 is one figure and in the table another - we do not correct anything on our own initiative. We mark the place and notify your team.

What we do not do

TARGMANEBI translates the documentation. The application to register a medicine is submitted to the Agency by the marketing authorisation holder or its authorised representative. Always check the current list of registration requirements against the Agency's official sources.

If part of the registration package requires a notarized translation - for example, a power of attorney or a manufacturer's letter - we prepare that too: notarization.

Turnaround, volume and confidentiality

A single leaflet, label or certificate is ready the same or the next day. For a complete registration package or the translation of a portfolio, we draw up a work schedule and deliver in stages, so that your team can review the work part by part.

A registration dossier is a trade secret. Only the team working on the project has access to the documents, and the content is not uploaded to AI systems or public machine translation services. In detail: privacy policy.

How we work with companies

Frequently asked questions

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