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Quality translations, deadlines, and a thorough
understanding of the pharmaceutical industry are pre-requisites
for Marketing Authorisation Applications (MAAs), whether by
the Mutual Recognition or Centralised Procedures. All documents
- including SPCs, PILs, Labelling, Patient Informed
Consent Forms, etc. - need to be translated adhering
to EU guidelines and in user-friendly language. The languages
naturally include all those of the EU Community and Eastern
Europe (including Icelandic and Norwegian), together with
Japanese, Chinese, Afrikaans and Hebrew.
See
Sankyo case study
See
TKT case study
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