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Regulatory affairs

If customers require local expertise within regulatory affairs in the North-Europe and Baltic area, LINK Medical can be trusted to deliver. We provide regulatory services related to human and veterinary products, including medical devices, medical gases, herbal medicinal products, food supplements and cosmetic products.

Our regulatory services cover small tasks as well as complex projects

It is easy to access our long experience from both the pharmaceutical industry and the relevant authorities in the region. All services can be delivered from our local offices in the Nordic and Baltic regions or from the customer’s own premises. International companies can also use LINK Medical as a local regulatory department.

Our regulatory affairs services for pharmaceuticals and medical devices cover small tasks as well as complex projects - from variations, renewals and translations to overviews, compiling of dossiers and regulatory strategies.

Services within Regulatory affairs:

  • Regulatory strategies
  • Preparation of dossier
  • Post approval support/maintenance of marketing authorisations
  • Catalogue text
  • Translations
  • Resourcing
  • eSubmissions

Related links:

Download our flyer Regulatory Affairs 

Related contacts:

Grethe Berven
Grethe Berven
Director Regulatory & Safety, Norway
Tel:+47 92 02 51 55 

Marianne Jonsson
Director Regulatory & Safety
Phone: +46 (0)725 235 100


7119 Anne K
Anne Krammer
Director Regulatory & Safety 
Tel: +45 61 67 32 15
Uwe Anzenberger
General Manager
Tel:+49 176 8227 0156
      +49  30 2461 2025