Pharmaceutical documents carry a level of regulatory and clinical weight that makes accuracy non-negotiable. A dosage instruction, contraindication, or excipient list translated incorrectly does not just cause a regulatory rejection; it can reach a patient or prescriber with the wrong information. That is why pharmaceutical translation must be handled by linguists with active knowledge of the therapeutic area, not generalists working from a medical translation dictionary.
Our pharmaceutical translation team works exclusively with translators who hold life sciences degrees or equivalent professional experience in the relevant therapeutic area. Every project goes through a three-stage review: translation, specialist review, and terminology verification against your glossary or our ICH-aligned term base. We maintain project memory so that consistency is preserved across the lifecycle of a product, from early clinical phases through post-approval variations and label updates.
Investigator meetings and regulatory consultations with international teams can be supported by our conference interpreting services.
IND, NDA, MAA, and ANDA dossiers for FDA, EMA, TGA, and national competent authorities. Module-by-module translation aligned with CTD structure and regional regulatory requirements. Version control and change tracking included.
Clinical trial documents including informed consent forms, protocol synopses, investigator brochures, CRFs, and patient diaries for trials run under GCP and ICH E6(R3). Every trial document gets subject specialist review.
Summaries of Product Characteristics and package leaflets (PIL) in EU languages and for other regulated markets, formatted to the EMA QRD template. Native-language review of patient-facing text for readability and clarity.
CMC dossier translation covering Chemistry, Manufacturing, and Controls documentation including specifications, validation reports, stability studies, and process descriptions. Terminology consistent with ICH Q8, Q9, Q10, and Q11 and across all CMC modules.
Individual Case Safety Reports, Periodic Safety Update Reports, Risk Management Plans, and REMS documentation. Terminology follows MedDRA, and formats follow EudraVigilance and local authority requirements. Handled in strict confidence.
Instructions for use, technical files, clinical evaluation reports, and labeling for medical device translation under MDR 2017/745 and IVDR 2017/746. Notified body submission formats supported.
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Yes. Every pharmaceutical translator we assign holds a life sciences degree or equivalent professional experience, and has direct experience in the relevant therapeutic area or regulatory pathway. For regulatory submissions, we also apply a second specialist review to verify that terminology matches the target authority's preferred nomenclature (for example, EMA preferred terms versus FDA preferred terms).
Yes. We build a product-specific translation memory and glossary from the first project and apply it to all subsequent work. This ensures that a term translated one way in the IND appears identically in the NDA, the SmPC, and every subsequent label variation. When ICH or authority-preferred terminology updates, we notify you and update the glossary.
We provide a signed statement of translator qualifications and a certificate of accuracy with every regulatory translation. If the receiving authority asks for a specific declaration under a national framework, contact us before you order so we can confirm whether our standard certificate covers it or additional attestation is needed.
Request a free quote for your pharmaceutical translation project. We confirm translator qualifications, turnaround, and price as quickly as possible.
