Pharmaceutical Translation
Pharmaceutical TranslationMedical Device Documentation Translation for EU Registration in 5 Countries
ISO 17100-certified translation of medical device technical documentation for EU registration, CE marking and MDR compliance by M21Global.
Read article
Pharmaceutical TranslationTranslating SmPC and Package Leaflets for INFARMED and EMA Submissions
Professional SmPC and PIL translation for INFARMED and EMA submissions. ISO 17100 certified, with linguists specialised in pharmaceutical regulatory texts.
Read article
Pharmaceutical TranslationTranslating SmPCs for the European Market: Requirements
SmPC translation for European market authorisation across all EU languages. M21Global, ISO 17100 certified by Bureau Veritas.
Read article
Pharmaceutical TranslationMDR User Manual Translation: Requirements and Certified Process
MDR-compliant user manual translation for medical devices. ISO 17100 certified by Bureau Veritas, covering all EU official languages.
Read article
Pharmaceutical TranslationTranslating Drug Registration Dossiers for EMA Submission
CTD dossier translation for EMA drug registration. M21Global, ISO 17100 certified, with more than 20 years in pharmaceutical translation.
Read article
Pharmaceutical TranslationGCP Documentation Translation for Multinational Clinical Trials
GCP documentation translation for international clinical trials. ISO 17100 certified by Bureau Veritas. Linguists experienced in ICH-GCP.
Read article
Pharmaceutical TranslationTranslating Patient Information Leaflets for EU Languages
PIL translation into all EU languages for regulatory compliance. M21Global, ISO 17100 certified, ensures patient safety through clear, accurate leaflets.
Read article
Pharmaceutical TranslationPharmacovigilance Report Translation for INFARMED and the EMA
How to translate PSURs, ICSRs and RMPs for INFARMED and the EMA: regulatory requirements, terminology pitfalls, and quality control process explained.
Read article
Pharmaceutical TranslationMedical Device Documentation Translation for MDR Compliance
Medical device documentation translation for MDR 2017/745 compliance: IFU, SSCP, labelling and technical files with ISO 17100 certification. Request a quote.
Read article
Pharmaceutical TranslationIFU Translation for EU Regulatory Compliance
IFU translation for EU MDR and IVDR compliance. ISO 17100-certified process, TEP workflow, terminology management and version traceability for medical devices.
Read article
Pharmaceutical TranslationTranslating Clinical Trial Protocols for Regulatory Submission
Translating clinical trial protocols for EMA, INFARMED and ANVISA submissions. Regulatory requirements, ISO 17100 quality process and amendment management.
Read article
Pharmaceutical TranslationPharmaceutical Compliance Translation: Precision for Global Regulatory Success
Pharmaceutical compliance translation for EMA, FDA and ANVISA. ISO 17100 certified linguists with pharma expertise. Free quote in 3 business hours.
Read articleNeed Professional Translation?
Request a free, no-obligation quote for your translation project.
Request Quote