Legal work in this sector
The regulatory side of this work falls under the HMG, the HFG and the EU CTR.
Licensing and intellectual property
Biotech licensing terms depend on the development stage, patent position and plans for commercialization. Exclusivity, field of use, royalties and option timing need to reflect those circumstances and address changes in the development timeline.
- Exclusive and non-exclusive license agreements
- Option agreements with milestone gates
- Royalty structures and benchmarking
- Field-of-use and territorial restrictions
Research collaborations
Sponsored research, CRO partnerships and academic collaborations need clear terms on intellectual property and publication. The agreements must address how compounds, data and know-how may be used in later commercial development.
- Collaboration agreements with milestone structures
- Sponsored research agreements
- Material transfer agreements
- Consortium agreements with multi-party governance
Clinical development
Clinical contracts span multiple jurisdictions and regulatory systems, from the EU CTR and ICH-GCP to Swiss KlinV. Each agreement (with CROs, investigators, and trial sites) must support both the regulatory submission strategy and the broader commercial development timeline.
- Clinical trial agreements
- CRO master services agreements
- Investigator and site contracts
- Manufacturing and supply agreements (CMO/CDMO)
Defined assignments
These standard assignments each carry a fixed fee, with a 50 percent uplift where priority handling is expressly agreed. Read what a fixed fee covers.
Quality agreement (GMP / GDP)
A fixed fee covers the GMP / GDP responsibility-allocation agreement for supply relationships, with a complete responsibility matrix and the non-delegable Swiss positions checked.
- Responsibility matrix with one accountable party per activity
- Change-control clause; the commercial supply agreement is scoped separately
International data-transfer package
A fixed fee covers the documented transfer assessment for the clinical, pharmacovigilance and research data flows to one vendor: mechanism selection, the six-step transfer impact assessment, the correct SCC module with the Swiss addendum, and a risk-rated conclusion.
- Documented six-step assessment, importer-specific
- Risk-rated conclusion with re-assessment triggers
- A reduced fixed fee for each further vendor
Working together
Fees are fixed, capped or phased, or run as a retainer; work beyond the agreed scope is billed by time.
For companies without a full-time legal role, fractional counsel provides part-time legal support on a days-per-month retainer.
To establish which rules apply, the regulatory posture audit reviews the laws relevant to one biotech or pharma product, assesses its compliance position and identifies the work needed to address each gap.
For cybersecurity and product-security questions, the cyber readiness assessment establishes which of NIS2, the Cyber Resilience Act and the ISG apply, with the resulting duties and deadlines. Research and manufacture of medicinal products sit in the high-criticality annex of NIS2, and a company holding a license under the HMG to manufacture, place on the market or import medicinal products must report qualifying cyberattacks to the BACS within 24 hours of discovery under the ISG.
Biotech and pharma matters are handled through these services:
- Regulatory posture audit
- Cyber readiness assessment
- Life sciences regulation
- Clinical trial contracting
- Health and research data
- Market access and reimbursement
- Pharmacovigilance and drug safety
- Product liability
- Pharma and MedTech transactions
- Compliance and investigations
- International arbitration
Explore the topics
Read related articles
- The 2026 EU Pharma Package: The Sponsor Decisions That Close Before Entry into Force
- Pharma R&D Partnerships: Contractual Risk Allocation
- Biotech Licensing: Hidden Contractual Pitfalls
- The 90-Day Rule: How the EU Pharma Package Rewrites Global Filing Strategy for US Sponsors
- AI in Drug Discovery: Intellectual Property and Data Ownership Challenges
- The Unified Patent Court at Year Three: Opt-Out Strategy for US Portfolios
- The Cross-Border Pharmacovigilance Agreement: What a Safety Data Exchange Contract Cannot Allocate
- Biosimilar Entry After the EU Pharma Package: The Exclusivity Clock Read from the Outside
- Nordic Health Data for Real-World Evidence: What Findata Grants a US Biotech, and What the EHDS Changes
- Denmark's 14-Day Clinical Trial Approval: The Nordic Race and the Clocks That Keep Running
Common questions
- What does a license agreement need to settle beyond the royalty rate?
- It needs to settle exclusivity, field of use, territory, option timing and the milestone gates that release each payment, each keyed to the stage of development, the patent landscape and the commercial pathway the parties expect. License structures that do not anticipate a timeline shift produce disputes years later, when the development path diverges from the assumptions the deal was priced on.
- Who owns the intellectual property created in a sponsored research collaboration?
- Ownership depends on the agreement. IP allocation and publication terms therefore need to be settled before work begins. The terms must allow compounds, data and know-how to be used in commercial development without encumbrance; publication rights without a review window can prevent that.
- Which rules govern a clinical trial run in both Switzerland and the EU?
- A trial conducted in both places sits under the EU CTR on the Union side and under the HFG with its KlinV on the Swiss side, with ICH-GCP applying on both, and the contracts have to serve both at once. Each agreement with a CRO, an investigator or a trial site must support the regulatory submission strategy and the commercial development timeline, because a clause that is convenient for one is often an obstacle to the other.
- Which assignments carry a fixed fee in this sector?
- The GMP / GDP responsibility-allocation agreement and the international data-transfer package for clinical, pharmacovigilance and research flows each carry a fixed fee, the package with a reduced fee for each further vendor. Other work runs on a retainer or on a capped or phased fee.