ISO 9001 
ISO 17100 
ISO 18587 LinguaVox provides professional pharmaceutical translation services for drug manufacturers, contract research organisations (CROs), regulatory affairs consultancies and biotechnology firms. The pharmaceutical industry operates under demanding international regulation, and we help companies handle multilingual content with precision, confidentiality and a structured delivery workflow. Working in translation since 2000, we manage pharmaceutical projects in more than 150 languages.
Pharmaceutical work depends on strict terminological consistency, controlled documentation processes and a clear understanding of the regulatory or commercial use of each file. Every request is assessed according to the source language, target language, country of use, therapeutic area, file format and submission deadline. A marketing authorisation application calls for different expertise from a patient-facing brochure or an internal manufacturing standard operating procedure.
Translating regulatory documentation and marketing authorisations
When a company seeks approval to market a medicine in a new territory, the regulatory submission involves substantial translation. We translate dossiers for the European Medicines Agency (EMA), the FDA and other national competent authorities, so that the language follows the terminology and formatting expected in that context.
Key documents at this stage include the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL) and product labelling. For the European market, our translators are familiar with the formatting and terminology of the EMA's Quality Review of Documents (QRD) templates. Following the correct QRD template and standard terms can help reduce avoidable queries during regulatory review.
Clinical study reports and drug development
The drug-development lifecycle produces a large body of data that has to be translated for international stakeholders. We translate clinical study reports, investigator brochures, clinical trial protocols and ethics committee correspondence.
Accuracy in clinical data is decisive. Translators working on these files need to be comfortable with pharmacokinetic and pharmacodynamic terminology and with the statistical methods used to present trial results. We assign this material to linguists with a genuine background in life sciences and clinical research.
Pharmacovigilance and drug safety reporting
Once a medicine is on the market, its safety has to be monitored across the product lifecycle. Pharmacovigilance translation calls for both speed and precision, since regulators set tight deadlines for adverse-event reporting. We translate Suspected Unexpected Serious Adverse Reactions (SUSARs), Periodic Safety Update Reports (PSURs) and individual case safety reports.
Because adverse-event reports often originate with doctors or patients in different countries, the source can range from technical medical description to a colloquial account of symptoms. Our translators convey the clinical reality of each report faithfully, so that the central drug-safety team can assess the risk properly.
Pharmaceutical manufacturing and packaging
Beyond research and regulation, the manufacture and distribution of medicines require multilingual support. We translate standard operating procedures (SOPs), batch manufacturing records, validation protocols and quality-assurance documentation for facilities working under Good Manufacturing Practice (GMP) guidelines.
We also translate packaging text, carton labelling and blister-pack foils. For packaging projects we frequently work alongside desktop publishing (DTP) specialists, so that the translated text fits the physical constraints of the design without compromising legibility or the regulatory wording.
Quality assurance and terminology management
Terminology management is exacting in the pharmaceutical sector. A particular compound, adverse reaction or manufacturing process should be translated identically across years of documentation. We use translation-memory software to maintain client-specific glossaries and keep terminology continuous across project phases.
Quality control is built into the workflow. Under ISO 17100, the translation is followed by a bilingual revision carried out by a second, independent pharmaceutical linguist, who checks the target text against the source for accuracy, appropriate terminology and alignment with the relevant regulatory style guides before delivery.
Requesting a pharmaceutical translation quote
The most reliable way to request a quote is to send the original files and set out the language pairs, deadline, country of use and delivery format. For regulatory submissions, please indicate whether the text must follow a specific template such as the EMA QRD guidelines.
Our quotations reflect the workflow that the document type and regulatory context genuinely require. Word count is a key factor, but the complexity of the therapeutic area, the presence of dense data tables and the need for independent revision or formatting will also shape the scope.
Frequently asked questions
Are your translators familiar with EMA QRD templates?
Yes. We can assign pharmaceutical translators and reviewers familiar with the EMA Quality Review of Documents (QRD) templates for SmPCs, PILs and labelling. Please send any current template or client instruction with the files so the translation follows the required format.
How quickly can you process urgent pharmacovigilance reports?
Adverse-event reporting often runs to tight regulatory deadlines. We assess urgent pharmacovigilance requests and, where feasible, assign priority linguists and reviewers according to language pair, volume, time zone and the required delivery format.
Do you translate both SmPCs and Patient Information Leaflets?
Yes. We translate documentation for healthcare professionals, such as Summaries of Product Characteristics, and patient-facing documents such as Patient Information Leaflets, adapting the terminology and register to the intended reader in each case.
Can you handle pharmaceutical packaging and labelling files?
Yes. We translate packaging text and can work with design files such as Adobe InDesign or Illustrator where layout is part of the project. Text expansion, line breaks and regulatory wording are checked before final approval.
What is the process for updating existing regulatory files?
When you have revised a previously translated document, we use translation-memory software to identify the new or amended text. The quote can then focus on the changed segments, together with any review needed to keep the updated file consistent.
