Regulatory Affairs

In Need of Additional Short- or Long-Term Regulatory Resources?

  • News
  • Read time: 4 minutes

LINK Medical offers customized solutions for your Regulatory Affairs needs across the Nordics.

Are you facing a peak in your regulatory workload? That’s when flexible interim insourcing is the ideal solution — and we currently have experienced consultants ready to help. Our RA professionals in Norway, Sweden, and Denmark can step in quickly, providing the expertise you need, exactly when you need it.

We have Regulatory Affairs Consultants available, both Jr and Sr, with extensive experience in the pharmaceutical industry, supporting areas such as:

  • Update of Product Information (SmPC, PL, labelling)
  • Artwork review and approval
  • Maintenance of MAs (e.g. variations, MA transfers, OTC switch)
  • Launch preparation
  • Translation/QC of educational materials, DHPC-letters, and other regulatory/scientific documents
  • Compliance and medical review of promotional and non-promotional materials
  • CMC regulatory competence — Writing & reviewing the Module 3 documentation

Let’s find the right setup for your team — get in touch to see how we can best support you.

📩 Contact us: bd@linkmedical.eu

We look forward to hearing from you!

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