Translation and localisation services for the pharmaceutical industry require the highest standards of quality and accuracy because they have a direct impact on people's lives and health. Quality localisation must meet compliance requirements in all aspects of the industry from R&D and manufacturing to distribution of products and services. The highly regulated pharmaceutical industry poses unique challenges to language service providers.
mLingua is the world's leading provider of localisation services for the pharmaceutical industry. Our ISO 9001:2008 and EN 15038:2006 standards enable us to deliver unprecedented levels of accuracy in the translation of extremely technical scientific and medical documentation under safety-critical conditions. Covering every aspect of the industry, from genomic and proteomic research to drug production projects, toxicity testing and monoclonal antibody therapy reports, mLingua has an extensively tested group of experts available at any given time to fulfil even the most demanding requirements.
Whether you are registering across all EU languages with the European Medicines Agency (EMA), or a select number of languages with local health authorities in Japan (PMDA), China (SFDA), or Korea (KFDA), among others, mLingua fulfils a broad range of international regulatory needs in all aspects of our service – from translation to desktop publishing to L10n process engineering and independent review and assessment. Our highly experienced and dedicated Global Regulatory Submissions team is available to help you satisfy rigorous multilingual filing requirements that range from turnaround time to cost and quality.
As a true pioneer in the provision of language support services to the pharmaceutical industry, mLingua offers a wide range of language and technology solutions and services, including:
- Clinical trial protocols
- Brochures and catalogues
- Drug packaging and labelling
- Manufacturing SOPs
- IRB/IEC documentation
- CMC documentation
- GMP audit reports
- Patient information leaflets (PIL)
- Summaries of product characteristics (SmPC)
- Common technical documents (CTD)
- Quality recognition documents (QRD).
For more information on how mLingua can meet your specific language service needs, please contact us at [email protected].