Outsourcing local regulatory affairs can take many forms, reflecting differences in company structures, product portfolios and market requirements. One company may need support with promotional material compliance, another with local language requirements and product information, while another may require ongoing post-authorisation support or local regulatory expertise in a specific market.
This is why Medfiles’ local regulatory affairs support is tailored to each client’s actual needs. Support can range from individual regulatory tasks and temporary resource needs to ongoing local regulatory activities and long-term market support.
Medfiles combines broad EU regulatory expertise with local expertise in the Nordic and Baltic countries, enabling support at both European and local market level.
The following case examples illustrate different situations where pharmaceutical companies have outsourced local regulatory affairs activities to Medfiles and how the scope of support has been adapted to their needs.
1. Keeping Nordic promotional materials compliant across multiple markets
Client’s need
A global pharmaceutical company managing a large product portfolio across several Nordic markets needed a reliable way to maintain compliance in its promotional materials. While many materials were used across multiple countries, national regulatory requirements and local industry practices added complexity and increased the risk of inconsistencies. Regulatory updates often require changes to promotional content, creating a continuous need for accurate updates and strong version control.
How Medfiles helped
Having already collaborated with Medfiles in regulatory affairs, the company turned to our experts for support with promotional material compliance and the maintenance of abbreviated product information.
Today, Medfiles provides ongoing compliance review, updates abbreviated product information and ensures that the latest approved content is consistently reflected in marketing materials.
Value for the client
The client has a reliable local partner for promotional material review and compliance support in Finland. This helps the client reduce compliance risks, streamline internal processes and confidently support compliant promotional activities across the Nordic region.
See also: Pharma marketing compliance in the Nordics | Pharmaceutical marketing in Finland – Q&A on requirements and compliance | Promotional material compliance in the Baltics
2. Preparing core product information for Nordic market entry
Client’s need
A pharmaceutical company preparing to seek marketing authorisation in the Nordic countries had English product information in place but needed regulatory strategy advice and support to comply with local language and regulatory requirements.
While the company had in-house expertise for one Nordic language, ensuring accurate and compliant product texts across the remaining markets required additional expertise and coordination.
How Medfiles helped
The client turned to Medfiles for a streamlined solution. Our experts reviewed existing translations, prepared and verified local product texts, and coordinated additional Nordic language translations through our trusted partner network.
In addition, Medfiles supported the review of packaging mock-ups and assisted with the submission process to national authorities.
Value for the client
By combining translation expertise with regulatory know-how, Medfiles helped the client efficiently prepare the application strategy and product documentation for multiple markets, simplify coordination, and support a smooth path towards marketing authorisation in the Nordic region.
See also: How to implement common Baltic packs for human medicines
3. Supporting post-authorisation regulatory activities across the Baltic markets
Client’s need
A global healthcare company operating across the Baltic markets needed additional regulatory expertise to support ongoing local regulatory activities and ensure continuity across multiple countries. Maintaining local compliance and managing market-specific requirements required resources and expertise that were not always available internally.
How Medfiles helped
Medfiles’ Baltic regulatory affairs team provides ongoing local regulatory support, working closely with the client’s global and regional teams. Support includes managing local regulatory requirements, coordinating authority interactions, maintaining product information, supporting post-authorisation activities and providing additional resources when needed.
The scope of support is adjusted as priorities and workloads change, ensuring continuity while maintaining local market expertise.
Value for the client
The client gains access to an experienced local regulatory affairs team without the need to maintain additional in-house resources in every market. The arrangement supports compliance with local requirements, provides operational continuity and enables internal teams to focus on strategic priorities.
4. Meeting Finnish requirements through outsourced Responsible Pharmacist support
Client’s need
An international pharmaceutical company expanding its operations into Finland required a wholesale distribution authorisation and, under Finnish legislation, needed to appoint a qualified Responsible Pharmacist (RP) to oversee the quality of medicinal product distribution.
Establishing a permanent local RP position was not practical. However, the company still needed continuous local expertise to support GDP compliance and interactions with the Finnish Medicines Agency, Fimea.
How Medfiles helped
Medfiles acts as the company’s Responsible Pharmacist, providing continuous local regulatory and quality expertise. Support includes maintaining the GDP quality system, reviewing and updating standard operating procedures, assessing deviations and change controls, monitoring product quality complaints, supporting transport and distribution quality issues, monitoring medicine availability obligations, and handling communications with Fimea where required.
Medfiles also provides local expertise during inspections, audits, service provider qualification activities and other regulatory or quality situations requiring additional support.
Value for the client
By outsourcing the Responsible Pharmacist role, the company has access to experienced local expertise without establishing a permanent position in Finland. The arrangement supports ongoing GDP compliance and provides continuity for both routine activities and unexpected regulatory or quality situations.
See also: Medfiles as LEO Pharma’s responsible pharmacist in Finland
Why outsource local regulatory affairs to Medfiles?
- 35+ years of experience and strong Nordic and Baltic expertise: Supporting pharmaceutical and healthcare companies since 1987.
- 40+ regulatory affairs experts based in Finland and the Baltics: Expertise across different products, procedures and regulatory disciplines.
- Support throughout the product lifecycle and across markets: From new marketing authorisations to post-authorisation activities, local compliance requirements and ongoing regulatory support.
- Flexible outsourcing models: Support for individual tasks, local market activities or broader regulatory responsibilities as needed.
See also:
- Regulatory outsourcing: choosing the level of support that fits your needs
- Embedded expert support for RA & PV teams: a flexible alternative to hiring and full outsourcing
Author: Mari Lindevall
Regulatory Affairs Expert
Mari joined Medfiles with a diverse background in pharmacy and the pharmaceutical industry. She holds a Master’s degree in Pharmacy from the University of Helsinki, with a major in Industrial Pharmacy, and has additional university studies and certifications in project management.
At Medfiles, she works in regulatory affairs with medicinal product information, marketing materials and packaging material artworks.
Her professional background includes experience in quality assurance, clinical research and both community and hospital pharmacy. Mari values the variety of her role and enjoys challenging client questions across the regulatory field, as they keep her continuously learning and motivated.
