Pharmaceutical, biotech, and medical device translation for FDA, EMA, Health Canada, PMDA, and NMPA regulatory submissions. NDA, BLA, IND, MAA, and CTD packages. Prescribing information, SmPC, patient medication guides, clinical evaluation reports, and pharmacovigilance documentation. GCP-compliant. ISO 17100. Global market expertise.
A poorly translated regulatory submission doesn't just delay approval — it can result in a Complete Response Letter, FDA information request, or Notified Body finding. Our regulatory translators understand the context, not just the content: what the agency is looking for, how findings are communicated, and what level of specificity the regulatory language requires.
Response within 2 business hours. Regulatory background confirmed upfront.
New Drug Applications (NDA), Biologics License Applications (BLA), Investigational New Drug (IND) applications, Marketing Authorization Applications (MAA), and ICH Common Technical Document (CTD) packages. FDA, EMA, Health Canada, PMDA, NMPA, ANVISA, and TGA submissions.
US Prescribing Information (PI/USPI), Summary of Product Characteristics (SmPC), patient package inserts, medication guides, Risk Evaluation and Mitigation Strategies (REMS) materials, and Highlights of Prescribing Information. Formatted for regulatory submission standards.
Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Individual Case Safety Reports (ICSRs), aggregate adverse event summaries, and signal management documentation. ICH E2 guidelines compliant.
Clinical study reports (CSRs), module 2 summaries, pre-clinical study reports, biostatistics sections, risk-benefit analysis, and integrated safety/efficacy summaries. Scientific accuracy reviewed by PhD-level translators in relevant disciplines.
Chemistry, Manufacturing, and Controls (CMC) documentation: manufacturing process descriptions, quality control specifications, stability data, analytical methods, and GMP compliance documentation. Pharmaceutical chemistry expertise applied.
Post-market clinical follow-up (PMCF) plans and evaluation reports, post-market surveillance plans, Periodic Benefit-Risk Evaluation Reports (PBRERs), and variation applications for label updates or manufacturing changes.
NDA, BLA, IND, ANDA, 510(k), PMA. CDER, CBER, CDRH submission requirements. 21 CFR compliance. FDA guidance document formatting. Spanish labeling requirements.
MAA, SmPC, PIL, EPAR. Centralised, decentralised, and mutual recognition procedures. All 24 EU official languages. EU MDR and IVDR compliance documentation.
Health Canada, PMDA (Japan), NMPA (China), TGA (Australia), ANVISA (Brazil), COFEPRIS (Mexico), MFDS (Korea), SAHPRA (South Africa). Market-specific regulatory formatting and terminology.
Life sciences translators need dual expertise: linguistic proficiency at a professional level AND scientific domain knowledge in the relevant field (pharmacology, clinical medicine, regulatory science, CMC, etc.). Our translators hold degrees in pharmacy, biochemistry, molecular biology, medicine, or biomedical engineering — plus translation credentials. For regulatory submissions, we require demonstrated experience with the specific regulatory framework (FDA, EMA, ICH) being translated for.
The ICH Common Technical Document (CTD) is the globally harmonized format for pharmaceutical regulatory submissions, used by FDA, EMA, Health Canada, PMDA, and most other major regulatory agencies. CTD modules contain clinical, nonclinical, CMC, and quality data. Translations of CTD submissions must preserve the technical meaning exactly — imprecise translation of safety data, manufacturing controls, or clinical findings can delay or derail approval.
Yes. For large regulatory submissions or ongoing pharmaceutical translation programs, we build and maintain project-specific term bases (glossaries) and translation memories. This ensures consistency across modules, languages, and time — critical when the same drug, compound, or device is discussed across 50,000+ word submissions in 20+ languages. We work in SDL Trados, memoQ, and other CAT tools.
ICH E6 Good Clinical Practice (GCP) guidelines include requirements for the translation and back-translation of clinical trial documents, particularly informed consent forms. GCP-compliant translation means the translation follows ICH E6 guidance: the original document is translated into the local language, a separate back-translation into English is performed by a different translator, and differences are resolved by a third party. We perform full GCP-compliant translation and back-translation workflows.
Pharmaceutical, biotech, and device regulatory translation with the scientific expertise your submissions require.