Key Areas of Healthcare and Life Sciences Expertise:

• Regulatory approvals and interactions with competent authorities
• Product launches and lifecycle management
• Clinical trials and research compliance
• Marketing practices and industry co-operation
• Public procurement and public sector contracting
• Licensing, distribution and supply agreements
• Research and development collaborations
• Investment transactions and strategic partnerships
• Regulatory investigations and disputes

We advise companies operating in highly regulated life sciences and consumer product sectors throughout the full product lifecycle, from early-stage research and product development to regulatory approval, market entry, commercialisation and post-market compliance.

Our experience spans pharmaceuticals, biotechnology and medical technology (medtech), as well as borderline products and other regulated products such as food and food supplements, cosmetics, and related consumer health products.

We support clients in navigating complex regulatory frameworks, ensuring compliance with applicable legislation, regulatory guidance and industry standards. This includes matters relating to product classification, clinical development, marketing and promotion, collaborations with healthcare professionals and organisations, market access, and ongoing regulatory compliance.

Advising on Complex Healthcare and Life Sciences Regulatory Matters

Clients engage us particularly when:

• Swedish or EU regulatory issues arise in relation to a medicinal product or medical device
• Clinical trials must be structured in compliance with applicable legislation, and the contractual relationships between involved parties such as Sponsors, CROs and investigators must be established
• Marketing or promotional activities are subject to industry and regulatory scrutiny
• Distribution or licensing arrangements require careful allocation of regulatory responsibility
• Legal expertise is required when participating in public procurement procedures or when contesting procurement decisions
• A regulatory investigation or dispute threatens market access or operations

Supporting Clients Across the Healthcare and Life Sciences Regulatory Landscape

We assist our clients in:

• Navigating complex healthcare and life sciences regulation
• Structuring compliant and commercially effective collaboration models
• Managing regulatory and competition law risks
• Securing market access through legally sound approval and procurement processes
• Resolving disputes and regulatory matters efficiently

Our objective is to safeguard compliance while enabling innovation and sustainable commercial growth in a highly scrutinised and rapidly evolving industry.

What distinguishes us is the integration of deep sector-specific regulatory expertise with a comprehensive understanding of commercial law, competition law, public procurement and dispute resolution. This enables us to provide coordinated and strategic advice across all legal dimensions of healthcare and life sciences operations.

Want to know more? Please contact: Malin von Heideken – Hammarskiöld