Pharmaceutical translations are a specialised service addressed to entities operating in a strictly regulated health care and life sciences environment. It is used primarily by pharmaceutical companies, drug importers and organisations responsible for registration processes and the introduction of medicinal products to new markets. In practice, these are entities for which precise, consistent language communication in compliance with applicable regulations is a real support in the safe and effective functioning on the domestic and international market.
Who do we provide pharmaceutical translations for?
This type of translation is addressed in particular to pharmaceutical companies, drug importers and companies providing registration services. It primarily includes written translations of the drug registration dossier and the so-called information leaflets: drug characteristics (SPC), patient information leaflet added to the drug packaging (PIL) and drug packaging labels. We perform this typo of translations on the basis of EMA terminological guidelines in order to standardise vocabulary, in accordance with pharmaceutical law. Translations of pharmaceutical texts are also translations of documentation regarding the validation of analytical methods in pharmacy (registration certificates, certificates of analysis), specifications, results of qualitative and quantitative physico-chemical tests of drugs and marketing translations (including advertising folders).
Pharmaceutical translations are one of the most difficult areas of translation – they must be extremely accurate and distinguished by precision in the selection of appropriate terminology. There is no room for error, as the consequences of inaccurate translations can be immense. Therefore, several teams are working on pharmaceutical translations, consisting of a translator, a consultant and a reviewer. An in-depth knowledge of the subject, supported most often by appropriate field education and many years of experience in translating similar texts, is an absolute requirement for people involved in this type of translation.
Who are our pharmaceutical translators?
Translators of pharmaceutical texts with whom we cooperate are people who have completed studies in pharmacy, medicine or a related field, and have mastered the given foreign language to a fluent degree. Among our translators of pharmaceutical texts are, among others, medical analysts, biomedical physicists, biologists and doctors. Thanks to proven procedures and an experienced team, we are able to provide you with professional support in the field of pharmaceutical translation at the highest level. Feel free to contact us – send us texts for a quote and we will advise you on the best solution!
Scope and application of pharmaceutical translations in market practice
It is worth emphasising that pharmaceutical translations are a real support not only at the stage of registration of medicinal products, but also throughout the entire cycle of their presence on the market. Companies operating in the life sciences sector operate in a highly regulated environment, where each document has a specific legal, information or operational function. Therefore, a professional pharmaceutical translator must understand the linguistic, business and regulatory context in which a given text will be used. This applies, among others, to communication with supervisory authorities, foreign partners, research centres or drug distributors. In practice, this means the need to work with very diverse materials that require a different translation approach, while maintaining terminological and formal consistency. Pharmaceutical translations include, among others:
documentation of clinical and non-clinical studies, where linguistic precision affects the correct interpretation of results by international research teams,
safety and pharmacovigilance reports, which must be unambiguous and in accordance with applicable procedures,
license agreements and corporate documents, combining specialist terminology with legal and business language,
training materials for medical representatives and staff, which must be understandable and at the same time consistent with the current state of knowledge.
In this context, business translations are also a natural complement to the offer, allowing to maintain the consistency of communication at a strategic level, especially in the case of companies conducting international activities and developing their product portfolio in many markets at the same time.
Competence and responsibility in the work of a pharmaceutical translator
The specificity of this industry makes the pharmaceutical translator particularly responsible for the quality of his work. Any wording may affect regulatory decisions, patient safety or the manufacturer's image. Therefore, the translation process is multi-stage and based on close cooperation of specialists from various fields. Knowledge of reference documents and industry guidelines also plays an important role here, as well as the ability to use translation memories and glossaries created specifically for a given client. In everyday practice, pharmaceutical translations very often intertwine with other areas of expertise. Therefore, the work on these projects also includes:
technical translations – necessary for descriptions of production processes, laboratory equipment or quality systems,
biotechnological translations – used in projects related to modern therapies, genetic research and biomedical engineering,
medical translations - support scientific and clinical communication at the interface between pharmacy and medical practice.
Such a wide range of topics requires not only excellent knowledge of the language, but also the ability to think analytically and interpret data. An experienced pharmaceutical translator is able to adapt the style and structure of the text to its purpose, ensuring that the translation is functional, consistent and in line with the expectations of institutional recipients. Thanks to this, pharmaceutical translations become a real support in product development, building brand credibility and efficient movement in the international regulatory environment.