Address: Papirkaia 8, Klosterøya, P.O Box 2870, NO-3702 SKIEN, Norway
Tel: +47 35 90 85 40 / +47 90 06 64 55
Fax: +47 35 90 85 49

Mericon AS

Established in 1990, Mericon AS is a Contract Research Organisation (CRO) based in Norway. Mericon provides you with the documentation through the marketing authorisation, the product launch and maintenance.

Our expertise covers:

Medicinal products - Marketing authorisations and translations of documents:

  • Control and submission of MA application dossiers to be submitted in Norway
  • Preparation and submission of Norwegian product information (SmPC, PIL, Labels)
  • Translation of RMP materials (safety materials)
  • Readability testing
  • Medical instructions for use
  • Norwegian pharmaceutical compendium texts
  • Summary of clinical documentations
  • Maintenance of marketing authorisations (variations etc.)
Medicinal products - Marketing material:
  • Checking marketing material for consistency with the Norwegian Law and national guidelines
  • Translation of smaller marketing material
  • Submission of marketing material to the Committee for Information on Medicinal Products
Traditional herbal medicinal products:
  • Advice and control of marketing authorisation documentation
  • Preparation and submission of Norwegian product information (SmPC, PIL, Labels)
Medical device:
  • Advice regarding legislation in Norway
  • Checking marketing material for consistency with the Norwegian Law and national guidelines
  • Translation of smaller marketing material
Contact

To learn more about Mericon's services and capabilities and how they can assist your business, please contact Mericon directly.



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