Sample documents for translation

Summary of medicinal product characteristics/Summary of product characteristics
package leaflets of medications and dietary supplements, package labelling (patient information leaflets)
documentation on validation of analytical methods

drug registration documentation, common technical document (CTD)
marketing materials and labelling of medications
descriptions of technological processes of drug manufacturing
scientific articles and publications

Compliance with the regulations that apply to the pharmaceutical industry

Various guidelines are applied, depending on the location where a drug is to be marketed. The regulatory authority in the European Union is the European Medicines Agency (EMA), in the United States it is the Food and Drug Administration (FDA) and in Japan it is the Ministry of Health, Labour and Welfare (MHLW). We most often complete pharmaceutical translations for companies and entities in the European Economic Area (EEA), based on the guidelines of the European Medicines Agency. EMA is responsible for scientific assessment of innovative medicinal products. The rules established by the Agency are available for all the entities manufacturing medicinal products and reflect the most recent conclusions on development of biomedical sciences.


Medicinal products are monitored for safety the entire time they are on the market. Actions associated with safety monitoring are subject to legal regulations applied worldwide. Pharmacovigilance (PhV) includes activities and studies associated with detection, assessment, understanding and prevention of adverse reactions or other problems arising from the use of medicinal products. Monitoring of adverse reactions (Pharmacovigilance) allows a rapid response at the moment of detection of risks associated with the use of drugs.

Translations of registration documentation

Registration of a drug requires the development of scientific and administrative documentation. In recent years, scientific documentation has been standardized and regulated by guidelines in order to make the process of registration of medicinal products clear for all the marketing authorisation holders. In order to achieve this, a Common Technical Document (CTD) documentation format was created that is binding for all the marketing authorisation holders responsible for a medicinal product.

Translations of product materials

Precise and unambiguous translation of the developed product materials guarantees patient safety. Information on the composition, indications, dosage, contraindications, interactions, warnings, adverse reactions and storage conditions are essential not only for patients, but also for medical staff. Translations of pharmaceutical content require particular care regarding the accuracy of terminology, numerical values or doses of a medicinal product. For translations of product documentation, we recommend a service that is compliant with the ISO 17100:2015 standard.

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