Marketing Authorization

We provide end-to-end regulatory support, ensuring compliance, efficiency and market access across the Nordic region and beyond. With deep expertise in regulatory frameworks, we streamline processes, manage interactions with authorities, and facilitate product approvals and lifecycle management. Our multilingual capabilities and strategic insights help clients navigate complex regulatory landscapes with confidence, enabling successful product launches, expansions, and ongoing compliance.

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Our Services:

New Marketing Authorisation Applications (MAA)
Maintenance of Marketing Authorisations
Update and translations of local language materials to and from all Nordic languages (Swedish, Danish, Norwegian, Finnish, Icelandic):
- Product information (SmPC
- PIL, labelling)Artworks and mock-ups
- Educational material
- Marketing material
MRP/DCP/national and centralized procedure
Regulatory agency interactions
CMC (variation assessments and documentation)
Variations, renewals, article 61(3) notifications, MAH transfers
OTC Switch applications (Rx to OTC)
Geographical expansion
Regulatory project management
Regulatory intelligence
Due diligence
eCTD

We are the Life Science Consulting Group

Our Services

Interim solutions Consulting & outsourcing Executive search Specialist recruitment Audits Nordic market entry PharmaRelations Academy Due diligence Interim Executives

Expertise Areas

Regulatory affairs Marketing Compliance Supplements & Food Cosmetics Marketing Authorization Nordic Regulatory Affairs Pre-Approval Regulatory Affairs

Medical Affairs Medical Writing

Sales & Marketing Digital & Social Media Data & Technology

Pre-clinical services Clinical development

Medical Engineering

Market Access

Medical Device and IVD ISO 13485 – Quality Management Systems MDR – Medical Device Regulation IVDR – In Vitro Diagnostic Regulation

Global Pharmacovigilance and Drug Safety Pharmacovigilance Local Pharmacovigilance Pharmacovigilance Audits and Inspections

Quality Assurance