Nordic Regulatory Services

Nordic Regulatory Services

A wealth of Nordic Regulatory Expertise, from a trusted partner

We are one of the largest Regulatory teams in the Nordics, with a deep knowledge of local regulations and guidelines for the pharmaceutical market in all countries (Sweden, Denmark, Norway, Finland and Iceland). Via a single point of contact we can offer complete life cycle management support in the Nordics for all your products. LINK Medical provides in-house expertise in Norway, Sweden and Denmark and manages Finland and Iceland through qualified vendors.

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Our Nordic Regulatory services ensure compliance and market access needs in all Nordic markets:

Consultation and expert advice on national legislation and specific requirements.
Advise, and review of activities and processes for healthcare compliance that fall under the EFPIA Code of Practice as well as national codes, practices, and legislation
Communication with National Competent Authorities
Regulatory strategy and market access including launch activities
Marketing authorization applications and maintenance (variations, renewals, etc).
Full Nordic compliance review on advertising and promotional material requirements for congresses, sponsoring, lobbying, donations, pre-launch, digital media etc.
Updates, translations and regulatory assessment of

Product information (SmPC, PIL, labelling)

Artworks and mock-ups

Educational material

Marketing material
Maintenance of local databases (e.g. Pharmaca Fennica, DKMAnet, FASS, Felleskatalogen)
Specific roles, e.g. Responsible person (RP), RP support, Qualified Person (QP),)
Full Pharmacovigilance Service Support

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Nordic Regulatory Services

Nordic Regulatory Services

Our Nordic Regulatory services ensure compliance and market access needs in all Nordic markets:

How can we help you?