Maintenance


 
As a Scandinavian CRO ( Contract Research Organisation) with offices in Oslo, Stockholm and Copenhagen, LINK takes care of all the steps involved in maintaining Marketing Authorisations, e.g.,
 
  • Variations
  • Transfer of Marketing Authorisations
  • Renewals
  • Periodic Safety Update Reports (PSURs)
  • Updating Summary of Product Characteristics (SPCs), labelling texts and package leaflets
  • User/readability testing of package leaflets
  • Proof-reading of labels and leaflets
  • Catalogue texts e.g Felleskatalogen and FASS

 

 
 

Related contacts

  Grethe Berven
Director of Regulatory Affairs & PV
Tel:(+47) 92 02 51 55
grethe@linkmedical.no
  Helen Larhammar
Senior Regulatory Associate
Tel:(+46) 706 04 10 59
helen@linkmedical.se 
  Marianne Holst
Managing Director
Tel: (+45) 22 15 85 56
marianne@linkmedical.dk

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