Regulatory Affairs

Medicinal Products & MedTech (Human & Veterinary)

Our experienced Regulatory Affairs consultants keep track of the constant development of the Pharma and MedTech legislation. We give advice on restraints and requirements, and help you choose the right strategy and procedure.

We package  the registration documents for submission, and carry out the negotiations necessary to obtain and maintain marketing authorisation. With us as your regulatory partner your product is in good hands.

Regulatory Affairs Manager

We provide full or shared regulatory responsibility in relation to:

Before marketing authorisation

  • Dossier audits (gap analysis)
  • Scientific advice
  • Regulatory strategy
  • Clinical trial applications
  • Marketing authorisation applications (MRP, DCP, CP, NP)

Post-approval

  • Variations
  • Renewals
  • PSUR procedures
  • ASMF procedures
  • Price and reimbursement applications

Regulatory support

  • Local requirements & legislation (Nordics)
  • Translations & updates of product information
  • Mock-up reviews
  • National databases in the Nordics (LiiV, DKMAnet, Farmalogg etc)
  • Nordic catalogue text updates (Fass, Felleskatalogen, medicin.dk)
  • eCTD creation and publishing
  • Marketing (promotional) material reviews (IMA certified)

Tarius/IQVIA

We are responsible for keeping the world wide regulatory intelligence database Tarius up to date, as regards Sweden and Norway.

Contact Maria Santesson for further information.