Regulatory Affairs

We offer high quality regulatory and marketing authorisation services for your medicinal products.

We have 20 years’ experience in regulatory affairs and work continuously to ensure compliance with current national and European regulations, guidelines and requirements. We work closely with the Norwegian regulatory authorities and regulatory spesialists in Europe.

General

  • Guidance according to national/European procedures (MRP/DCP/CP) and requirements
  • Contact with the Norwegian Medicines Agency (NoMA)
  • We act as a contact point for national issues in European procedures, including applications and maintenance of marketing authorisations

Human and veterinary medicinal products

  • Review and submission of marketing authorisation applications to the Norwegian Medicines Agency (NoMA)
  • Translation (primarily from English) and submission of Norwegian product information (Summary of Product Characteristics/Labelling/Package leaflet/Annexes)
  • Review/approval of packaging materials for submission and printing
  • Maintenance of marketing authorisations (applications for variations, renewals etc.)
  • Carry out readability tests (user tests) of Norwegian package leaflets
  • Preparation and submission of Norwegian additional risk minimisation measures materials (educational materials/RMP materials)
  • Preparation and updating texts for the Norwegian Pharmaceutical Compendium (Felleskatalogen)

Herbal medicinal products

  • Review and submission of marketing authorisation applications to the Norwegian Medicines Agency (NoMA)
  • Translation (primarily from English) and submission of Norwegian product information (Summary of Product Characteristics/Labelling/Package leaflet/Annexes)
  • Maintenance of marketing authorisations