Pangeanic places immense emphasis on the quality and accuracy of its translation services in the medical industry, where the accuracy of pharmaceutical translations has a direct effect on patients’ lives.
The pharmaceutical industry operates on a global scale. It has to provide translated materials to countless markets speaking many languages. Regulatory submissions to pharmaceutical agencies,packaging labels, patient information leaflets… if the information they contain is not translated with absolute accuracy, irrevocable and undesirable consequences can occur.
Quality Pharmaceutical Translations
Pangeanic has a dedicated department and staff knowledgeable of the intricacies of translating for the pharma industry. Our pharmaceutical translations are strictly compliant with the requirements of our certifications
- ISO 13485
- ISO 17100
(especially developed for translation services providers)
Pangeanic has over a decade of experience in all fields in healthcare (medical devices, pharmaceutical translation) as well as with very technical documents, such as:
- Case Report Forms
- Instructions-for-use inserts
- Documentation for training courses
- Clinical study protocols
- Informed consent forms
- Patent translations and patent applications
- Packaging, labeling
- Investigator brochures
- Linguistic QA in our Medical Quality Assurance process
We are pharma translation subject-matter-experts
Pharmaceutical companies can spend up to 10 years (and more!) and millions of dollars or euros to get a new drug to market. It is a lengthy and expensive process and we understand it. Clinical research and drug manufacturing is increasingly taking place in multiple countries and in multiple languages. This is why quality language services can help bring a drug to market faster and can help streamline the clinical trial process. Translation services may be required at several stages, from clinical research to regulatory submission and review, production and of course packaging, labeling and marketing.
At Pangeanic, your pharma translation projects are performed by selected native speakers, especially pre-qualified to match your field or medical sector. They are professionals who work exclusively in the medical industry with in depth technical and practical knowledge possessing relevant studies and specialization courses, from University degrees to Masters’, PhD / Doctorates.
Regulation Compliance: Submissions to the European Medicines Agency
Pharmaceutical companies looking to extend the reach of their treatment across national frontiers know that to register their drugs in a foreign market (for example the EU), a Summary of Product Characteristics (SmPC) must be submitted to the European Medicines Agency or to the authorities of the member state. This SmPC must be submitted in the language of the member state. Pangeanic has handled multiple pharmaceutical translation projects and assisted our clients in meeting all application and registration requirements.
The EMA website offers guidelines for preparing the SmPC documents, in each of the relevant languages. Pangeanic provides translation of SmPC documents in all of the European Union official languages, as well as the languages of the EEA-EFTA states (Icelandic and Norwegian). We are also contractors for machine translation services and language database services to the EU.
Because of our experience, Pangeanic is your partner of choice to help you with pharmaceutical translation projects. For example, in the European case, once the SmPC documents have been submitted to the EMA, the SmPC translations are sent to the Member States (MS) for linguistic review. The review is done by members of the QRD (Quality Review of Documents) team. The templates can be found on the EMA website. The EMA or its QRD representatives carefully check the translation to determine if it is acceptable in the member state concerned or through the EU. These representatives will also submit requests for document revision if they deem it necessary.
Conversely, in the US, Pangeanic has worked with European and Asian manufacturers to ensure their smooth submission and federal approval from:
- The Food and Drug Administration (FDA)
- Ethics Committees
- Institutional Review Boards
Service Support and Timely Translation Delivery
This is when the experience of a good translation company shows. Did you know that the time window allowed by EMA for submitting the translations, after approving the source SmPC document is, typically, 5 days? This means a lot of preparatory work and a developing a close relationship with your translation services so the documentation is in a perfect state for submission before you submit your SmPC. Get ready for any small changes to be applied in your documentation – and this is no mean feat. Our translation tools and translation databases can help you re-construct all your documentation with any terminology changes applied at a record time.
Our philosophy is “first-time right” and draws in our history supplying translation services to the Japanese industry. Our pre-selected medical translation experts and decades of pharmaceutical translation services experience offer you:
- Glossary creation / maintenance
- Source document editing
- Review and in-country validation management
- Back translation if required
- Readability testing of patient information leaflets