The DWL team - consisting of experienced specialist medical translators and project managers - offers the following translation service for Marketing Authorisation Applications and Variations for both human and veterinary medicinal products.
- Translation of Product Information (Annexes I to III) –
Summary of Product Characteristics, Labelling and Package Leaflet from English into all EU and EEA languages.
- Quality Control and Project Management
- Liaising with the client, translators and reviewers to ensure that all translations are complete, comply with EMA QRD requirements and meet agreed timelines.
- Managing client changes prior to, and after, submission.
- Managing the outcome of the linguistic review including discussion with, if requested by the client, a representative of the individual National Competent Authority (NCA).
- Type Ia/Ib and Type II Variations to existing Marketing Authorisations
Smaller in size than the full scale Centralised Procedure, we offer the same careful and high quality translation and project management service.
- Mutual Recognition, Decentralised and Referral Procedures
Consisting of fewer languages compared with the Centralised Procedure, the same high quality translation and project management approach is applied.
- Common Technical Document (CTD)
The full capability of DWL’s translators and project managers, in terms of subject matter and size, is demonstrated in the translation of the whole CTD or the following parts:
- Clinical overviews and summaries
- Non-clinical overviews and summaries
- Quality, Safety and Efficacy Expert Reports
