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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 
Updated

Related contacts:

Grethe Berven
Grethe Berven
Director Regulatory Affairs & PV
Norway
Tel:+47 92 02 51 55 
grethe@linkmedical.no
280x180- Jan
Jan Hellqvist
Managing Director
Sweden 
Tel: +46 70 913 51 25
jan@linkmedical.se
7119 Anne K
Anne Krammer
Pharmacovigilance and Regulatory Affairs Manager 
Denmark
Tel: +45 61 67 32 15
annek@linkmedical.dk
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Uwe Anzenberger
Regulatory Country Manager
Germany
Tel:+49 176 8227 0156
      +49  30 2461 2025
uwe.anzenberger@linkmedical.de