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Products and Services
We coordinate
We specialise in
- Preparation of package leaflets (PIL)
- Support for clinical trials
- Translation of SmPC/PL/Labelling in MRP/DCP and CP
- European-wide bridging projects
- QRD template updates
- Checking MedDRA terminology
- Variations – support services
- Global linguistic validation service
We advise on the following
- Writing for patients
- Process management, quality management and project management
- Regulatory requirements for product information in the EU (advice on compliance)
- Use of software in translation and localisation processes
- Quality assurance in the language process
- Software in translation and localisation processes
We program
- Semi-automated control software
- Multilingual websites
- Interfaces for existing software
- Programming of macros for Microsoft Office
- Web applications
- Database solutions for the language process
- Web-based terminology management
- Web-based document management
Registrated to DIN EN ISO 17100:2016-05