Clinical trial documents, Norwegian Medicines Agency submissions, pharmaceutical dossiers, and patient materials translated by Norwegian medical specialists.
Norway participates actively in European clinical research and has its own medicines regulatory authority, the Norwegian Medicines Agency (Statens Legemiddelverk), which operates within the EMA framework but with specific national requirements. Norwegian patient-facing materials must be written in clear, natural Norwegian for both Bokmal and Nynorsk variants where relevant. Our Norwegian medical translators hold degrees in medicine, pharmacology, or life sciences and are fluent in Norwegian regulatory and clinical documentation standards.
In-depth knowledge of Statens Legemiddelverk submission requirements for drug registration and medical device authorization within the EMA framework.
Translation, editing by a second Norwegian medical linguist, and a final terminology check against validated Norwegian medical glossaries.
Patient materials and public health documentation produced in Bokmal by default, with Nynorsk versions available when required.
Patient information leaflets and informed consent forms reviewed for accuracy and clarity for Norwegian-speaking patients.
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Google review (SL) , 10 months ago
“Highly professional and meticulous work. They truly listened to my needs and communicated very responsively. Very satisfied with the work done.”
Google review (FR) , 2 months ago
“Great communication, perfect translations in different languages in a very short notice. I would recommend! We are very pleased, thank you :-)”
Google review (INTL) , a year ago
Yes. We produce Norwegian-language regulatory documents for Statens Legemiddelverk, meeting the Agency's requirements for drug registration and medical device marketing authorization within the EMA framework.
Yes. We produce medical translations in Bokmal as standard, which is used by the majority of Norwegian speakers. Nynorsk versions are available upon request for documents requiring both official written standards.
Yes. We coordinate Norwegian clinical trial translation as part of multi-country Nordic or European studies, ensuring consistent terminology across all language versions.
Norway follows the EU GDPR via the EEA Agreement, enforced nationally through the Norwegian Data Protection Authority (Datatilsynet). Patient records, clinical data, and any personal health information processed during a translation project are handled under strict GDPR-equivalent safeguards. Files are transferred via encrypted channels, access is restricted to the assigned translator and reviewer, and all project data is deleted after final delivery unless a retention agreement is in place.
Yes. While the majority of Norwegian regulatory submissions to Statens Legemiddelverk use Bokmal, patient-facing materials distributed in certain regions may require Nynorsk versions. We manage both variants within a single project workflow, applying consistent medical terminology across both written standards and flagging any Bokmal-to-Nynorsk adaptation choices for client review.
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Send us your norwegian medical translation files, language pairs, and deadline. We will confirm specialist availability, certification needs, and a clear quote as quickly as possible.
