Our regulatory affairs associates possess experience from a variety of therapeutic areas, and can also consult our medical professionals.
We focus on linguistic accuracy as well as compliance with mandatory templates, e.g.QRD (quality review of documents templates.
As a Scandinavian ( CRO) Contract Research organisation LINK offer translation of a variety of documents between English, Norwegian, and Swedish, Danish e.g:
- Summaries of Product Characteristics (SPCs)
- Labelling texts
- Package leaflets
- Product information texts (SPCs, labelling texts, package leaflets)
- Commercial material
- Information for health care professionals
- Patient Information (PI)/ Informed Consent Forms (ICF)
- Medical records e.g., in case of a Serious Adverse Event (SAE)
- ‘Dear doctor’ letters
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