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 carried out 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 in 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