From IND and MAA submissions to SmPC and PIL documents, pharmaceutical translation demands precision that goes beyond fluency. Our specialist translators combine native-language expertise with life sciences backgrounds and a thorough grounding in EMA, FDA, and ICH guidelines.
Why Pharmaceutical Translation Requires Specialists
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.
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.
Pharmaceutical Document Types
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.
Client Reviews
“Excellent service and good value translation company. Accurate, fast turnaround at competitive rates. Highly recommended for their outstanding communication and prompt responses.”
Verified Google Review
“The team was meticulous with scientific and academic terminology. They delivered a flawless translation of my doctoral thesis on time, and communication throughout was outstanding.”
Academic Translation Client
“My experience with BeTranslated was great. They respond quickly and I recommend the agency 100%.”
Verified Google Review
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.
Related Services
Request a free quote for your pharmaceutical translation project. We confirm translator qualifications, turnaround, and price within one business day.