DAEN

MENU

Life science

We help life sciences companies, investors and public authorities navigate the legal, regulatory and commercial issues that arise across the sector. We advise across the life sciences sector - from pharma, biotech and medtech to health tech, digital health, diagnostics, clinical trials and other regulated healthcare products.

We help life sciences companies, investors and public authorities navigate the legal, regulatory and commercial issues that arise across the sector. We advise across the life sciences sector - from pharma, biotech and medtech to health tech, digital health, diagnostics, clinical trials and other regulated healthcare products.

Life science - a key growth sector for the years ahead

Life sciences is one of Denmark’s most important business strengths and a key growth area towards 2030. The sector is characterised by growth, internationalisation and a high level of innovation, but also by extensive regulation, authority requirements, data protection, public-private collaboration and complex commercial decisions.

Comprehensive legal advice at every stage

Our advice covers the full journey from development, establishment and financing to regulatory matters, authority dialogue, approvals, commercial collaborations, market access, pricing and reimbursement, M&A and disputes.

We assist with, among other things:

  • regulatory matters, authority dialogue, marketing authorisations and other regulatory approvals, including legal and commercial issues relating to the approval, variation, transfer and maintenance of authorisations and approvals;
  • clinical trials, research collaborations, R&D agreements, technology transfer and regulatory planning throughout the product development and commercialisation cycle;
  • data protection, health data, use and development of AI solutions and digital health solutions;
  • patents, copyright and trade marks, parallel import, protection and enforcement of rights, licence agreements, commercialisation and strategic collaborations;
  • licensing of and access to rights-protected content, including data licences, agreements with publishers and other rights relating to research, development and commercialisation;
  • market access, marketing, advertising, compliance, pricing and reimbursement, and relationships between industry and healthcare professionals;
  • quality, documentation and compliance requirements relating to development, manufacturing, distribution and clinical trials, including compliance reviews, audits, regulatory inspections and post-market obligations such as safety monitoring, reporting and recalls;
  • manufacturing, supply, distribution, supplier relationships and commercial contracts;
  • public procurement, competition law, EU law, innovation partnerships and public-private collaborations on the development, testing and implementation of new healthcare solutions;
  • investments, financing rounds, incentive schemes, shareholder matters, M&A, portfolio transfers, joint ventures and exit processes; and
  • product liability, insurance, risk management, enforcement, litigation, arbitration, mediation and other forms of dispute resolution.

Our approach is practical and multidisciplinary. As a full-service law firm, we assemble teams of specialists across the relevant legal disciplines, ensuring that our advice reflects the applicable regulatory framework, the client’s commercial objectives and the public-sector or international context in which many life sciences projects operate.