For almost two decades, LINK Medical and Medfiles have worked in close partnership, combining their strong local expertise across the Nordic and Baltic regions. Both companies are well established in their home markets and have a long-standing reputation as trusted business partners.
Even though many activities are harmonised at the European level, the Nordic and Baltic areas are not just two regions – they consist of eight independent countries, each with its own local laws, regulations, and languages. Through our partnership, clients gain seamless access to all eight markets and local services via a single point of contact and unified processes.
“The collaboration between LINK Medical and Medfiles offers clients a strategic advantage by combining our expertise across the Nordic and Baltic countries, ensuring compliance and efficient processes throughout the product lifecycle,” says Heta Karvinen, Director of Pharma Regulatory Affairs at Medfiles.
Complementary strengths for efficient local support
Together, LINK Medical and Medfiles offer efficient, high-quality services within regulatory affairs, marketing compliance, GDP/launch activities, pharmacovigilance, and clinical research in the Nordic and Baltic countries – making us more versatile together than alone.
Typical local services include:
Monitoring country-specific regulatory and pharmacovigilance requirements
Translating product information texts and checking labelling/mock-ups
Updating local databases (e.g., Pharmaca Fennica, DKMAnet, FASS, Felleskatalogen)
Reviewing promotional materials in line with local regulations
Scientific and medical literature monitoring, and handling of local adverse events
Medical information
Translating and submitting additional risk management materials
Medfiles brings in-depth expertise in Finland, Estonia, Latvia, and Lithuania, while LINK Medical provides in-house expertise in Norway, Sweden, and Denmark, and manages Iceland through a qualified vendor.
In addition to providing country-specific support, the collaboration enables coordinated coverage of the entire Nordic and Baltic region.
“When reviewing marketing materials or labelling texts, we are always looking ahead and considering opportunities for multilingual alignment and harmonisation across the Nordic countries. We see great value for our clients in offering a full Nordic review to support the use of common materials and packaging across the region,” says Christin Sjöstedt, Regulatory Group Manager at LINK Medical.
Smooth partnership for the client’s benefit
The LINK Medical and Medfiles teams meet regularly to exchange insights and plan future collaboration. For clients, this cooperation ensures seamless multi-country service – with no need to manage activities separately in each country.
Both companies are committed to quality and share a culture of reliability and punctuality.
“Our long-standing partnership benefits our clients through efficient and consistent ways of working. We maintain mutual trust by respecting agreed delivery times and following through on commitments. We are committed to continuous skill development to deliver greater value” says Kristine Nygren, Director Regulatory at LINK Medical.
“We share a strong alignment when it comes to quality and efficiency. Our collaboration runs smoothly, and we both can always rely on each other to handle tasks thoroughly and with care. With our team focusing on Finland and the Baltics, and LINK Medical covering Denmark, Norway, Sweden, and Iceland, we’re able to efficiently deliver high-quality work across the Nordic and Baltic regions to our clients,” says Linda Uotila, Regulatory Affairs Expert at Medfiles.
LINK Medical and Medfiles are also united by a forward-looking mindset – curious about the potential of AI and always exploring ways to improve everyday practices.
