Insights

Where regulation, contracts, and borders intersect.

Analysis of the regulatory, contractual, and cross-border questions that recur across Biotech, Pharma, MedTech, and ICT.

Pharma R&D Partnerships: Contractual Risk Allocation

Biotech Clinical Manufacturing: Regulatory Gray Zones

Data Privacy in Clinical Trials: GDPR Meets DSG

Pharma Supply Chain Liability: When Contracts Meet Reality

Swiss Authorized Representative Requirements Under EU MDR/IVDR

Cell and Gene Therapy Licensing: Navigating the Hospital Exemption

Software as a Medical Device (SaMD): Classification Pitfalls

Pharma Distribution Agreements: Parallel Import Protection in Switzerland

Swiss Professional Secrecy and International E-Discovery

Regulatory Sandbox for Digital Health in Switzerland

Clinical Evidence for SaMD: Regulatory Expectations

Post-Market Surveillance for SaMD: When Software Keeps Changing

AI-Enabled Medical Devices: The Regulatory Convergence Problem

EU MDR Compliance for Swiss MedTech: The Dual-Track Reality

AI in Drug Discovery: Intellectual Property and Data Ownership Challenges

Cloud Service Contracts: Jurisdictional Complexity

Biotech Licensing: Hidden Contractual Pitfalls

Cybersecurity Requirements for Connected Medical Devices: NIS2 Implications

Cross-Border Clinical Trial Agreements: Swiss-EU Coordination Post-Brexit

Swiss MedTech Export: Navigating Third-Country Status

Biotech M&A Earnouts: Anatomy of Milestone Disputes

Cybersecurity for SaMD: Meeting MDR and Beyond

Swiss Pharma Pricing Under Pressure: What the Three-Year Review Means for R&D Investment

EU AI Act and German Pharma R&D: The 2026–2027 Compliance Cliffs

Austria's Accelerated Clinical Trial Pathway: What the 35-Day Timeline Does Not Tell US Biotech

Nordic NIS2 Enforcement: A Fragmented Cybersecurity Landscape for Pharma R&D

Clinical Trials with Pregnant Participants in Switzerland: When Protection Becomes Exclusion

Three Jurisdictions, One Evidence Gap: Cross-Border Clinical Trials with Pregnant Participants

Clinical Trials with Pregnant Participants Under the EU CTR: The Gap Between Permission and Practice

Including Pregnant Participants in US Clinical Trials: The Regulatory Architecture of Good Intentions

The 90-Day Rule: How the EU Pharma Package Rewrites Global Filing Strategy for US Sponsors

The New Orphan Math: Product-Based Exclusivity and What It Does to US Rare-Disease Biotech

Access Conditionality and the New Cost of Selective EU Launch: What Article 56a Means for US Originators

Bolar at the Border: Expanded Carve-Outs and Earlier Generic and Biosimilar Entry into the EU

Transferable Exclusivity Vouchers: Will the EU's Antimicrobial Pull Incentive Actually Work for US AMR Developers?

Environmental Risk Assessment Reaches Across the Pacific: Supply-Chain ERA Obligations for US Manufacturers Using Asian APIs

Regulatory Sandboxes for Novel Therapies: A New EU Pathway for US Cell, Gene, and AI-Enabled Therapeutics

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