From IND and MAA submissions to SmPC and PIL documents, pharmaceutical translation demands precision beyond fluency. Specialist translators combine native-language fluency with EMA, FDA, and ICH grounding.
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 dictionary.
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.
Informed consent forms, protocol synopses, investigator brochures, CRFs, and patient diaries translated in accordance with GCP guidelines and ICH E6. Qualified translation with subject specialist review for every trial document.
Summary of Product Characteristics and Package Inserts for all EU member states and other regulated markets. EMA QRD template compliant. Native-language review for patient-facing text to confirm readability and clarity.
Chemistry, Manufacturing, and Controls documentation including specifications, validation reports, stability studies, and process descriptions. ICH Q8, Q9, Q10, and Q11 aligned. Consistent terminology across all CMC modules.
Individual Case Safety Reports, Periodic Safety Update Reports, Risk Management Plans, and REMS documentation. Translated to meet EudraVigilance, MedDRA, and local authority requirements. Confidential and audit-ready handling.
Instructions for use, technical files, clinical evaluation reports, and labeling for medical devices under MDR 2017/745 and IVDR 2017/746. Notified body submission formats supported.
“Excellent service and good value translation company! Efficient, accurate, and fast turnaround at competitive rates. Highly recommended for their outstanding communication and prompt responses on the chat.”
Google review (SL) , 2 years ago
“Amazing service! Very professional and quick. Greta communication via WhatsApp and email. I needed my documents very last minute and BeTranslated bent over back to help me with it, delivering hard copy too! Thank you - will use them definitely again in future.”
Google review (SL) , 9 months ago
“Great communication, perfect translations in different languages in a very short notice. I would recommend! We are very pleased, thank you :-)”
Google review (INTL) , a year ago
Yes. Every pharmaceutical translator we assign holds at minimum a life sciences degree and has direct professional 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 vs 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. For projects where the receiving authority requires a qualified person declaration under a specific national framework, contact us to confirm whether that requirement is covered by our standard certification or requires additional attestation.
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