Complex Science. Clear Counsel.

Scope

One product or product line rated across its whole applicable regulatory surface, in one of three industry sets: biotech and pharma, MedTech, or ICT and digital health. Applicability is determined instrument by instrument, each applicable obligation group is rated green, amber or red against a pinpoint citation, and the amber and red findings become a prioritized register with the deliverable that closes each one. The rating is a triage signal that sets the order of action, not a reasoned opinion on a single question.

Target client

US and EU companies placing a product on the Swiss or EU market, and in-house teams that need one prioritized view of the surface before committing budget to a single framework.

Billing

Fixed fee, set before work begins

Scope

One product or entity assessed against the EU and Swiss cyber and product-security stack, in one of three sets: MedTech, software and cloud vendors, or pharmaceutical developers and manufacturers. The assessment settles whether the Cyber Resilience Act reaches the product and in which class, whether the entity is essential or important under NIS2 and under which national transposition, and whether the Swiss 24-hour reporting duty reaches it; it then puts the dated duties on one calendar, rates the documentation against them and lists the clauses the cloud, supply and support contracts must carry. It is a legal applicability and gap review, not a penetration test, a technical audit or a certification. What the assessment covers.

Target client

Software and hardware vendors selling into the EU, device and IVD makers meeting the medical-device and cyber overlap, and pharmaceutical developers caught as sector entities.

Billing

Fixed fee, set before work begins

Scope

One AI medical device or in vitro diagnostic already in a notified-body procedure, assessed for readiness against the EU AI Act as a delta over the technical documentation and quality system the manufacturer already maintains. The assessment confirms the high-risk determination that follows by operation of law, establishes that the AI Act requirements are assessed inside the existing conformity procedure rather than beside it, rates each of the seven high-risk requirements against the file, and dates the obligations on the limb that applies. It is a readiness opinion, not a conformity assessment, which only the notified body can give. What the assessment covers.

Target client

Manufacturers of AI devices and IVDs in or approaching a notified-body procedure, and hospitals or health systems deploying a CE-marked diagnostic.

Billing

Fixed fee, set before work begins

Scope

Ongoing regulatory advisory under HMG, AMBV, advertising and integrity-and-transparency rules (AWV, VITH). Includes Swissmedic correspondence review, promotional material legal review, and a fixed allotment of advisory hours each month. Tier II ("Fractional Head of Regulatory Legal") available for clients with deeper engagement.

Target client

Foreign biotech / MedTech with Swiss subsidiary and no in-house Swiss counsel; Swiss Series A to C biotechs without GC.

Billing

Monthly retainer

Scope

Ongoing MDR/IVDR compliance support including PMS review, vigilance legal review, AR/PRRC contract maintenance and EUDAMED queries. CH-REP mandate structuring and review and Swiss market-entry counsel under the MepV for manufacturers without a Swiss presence. The firm structures and advises on the CH-REP arrangement; it does not act as the representative. Discrete workstreams (AR/PRRC agreement packages, economic-operator structuring under Art. 16 MDR, labeling review) priced as fixed-fee modules.

Target client

Swiss MedTech SMEs exporting to EU; non-EU MedTech entering CH and EU markets in parallel.

Billing

Fixed-fee modules + monthly retainer

Scope

Clinical Trial Agreement review and negotiation for site or sponsor, regulatory queries under HFG/KlinV and EU CTR, and master CTA template development. Volume-based framework retainer with per-CTA fixed fee for predictable cost per protocol.

Target client

Cantonal and university hospitals running investigator-initiated trials; mid-size CROs in DACH; Swiss biotech sponsors of EU/UK trials.

Billing

Framework retainer + per-CTA fixed fee

Scope

Legal support for Specialty-List (SL) listing applications and re-evaluations, BAG pricing and economic-evaluation procedures against the WZW criteria (efficacy, appropriateness, economy), price-review and re-examination proceedings, and reimbursement strategy under the KVV and KLV.

Target client

Pharma marketing-authorization holders seeking Swiss reimbursement; foreign manufacturers entering the Swiss reimbursed market; companies defending SL price re-evaluations.

Billing

Phase-based fixed fee + hourly

Scope

Legal support for the pharmacovigilance system under HMG and AMBV and EU GVP: safety-reporting obligations, QPPV and safety-data-exchange agreements (SDEA), signal-management and CAPA legal review, and audit and inspection readiness.

Target client

MAHs and affiliates operating Swiss/EU PV systems; companies outsourcing the QPPV interface; sponsors structuring safety-data exchange with partners.

Billing

Monthly retainer + fixed-fee modules

Scope

Product-liability risk advisory and defense under the PrHG and the OR: liability allocation across the supply chain, recall and field-safety-corrective-action legal coordination, and defense of product-liability claims.

Target client

Pharma and MedTech manufacturers and importers managing product-liability exposure; companies coordinating recalls / FSCAs; defendants in product-liability claims.

Billing

Hourly advisory; defense quoted per matter

Scope

For Swiss controllers: the voluntary data-protection advisor function under Art. 10 DSG, which lets the controller consult its advisor instead of the EDÖB before high-risk processing flagged in an impact assessment. Ongoing operations throughout: DPIAs, cross-border-transfer assessments, records of processing, and breach-notification readiness. The Swiss representative role under Art. 14 DSG and EU AI Act work are separate services; see the Swiss Data-Protection Representative and EU AI Act Compliance tiles.

Target client

Swiss controllers wanting an independent data-protection advisor; companies needing ongoing DPIA, transfer, record-keeping and breach support.

Billing

Monthly retainer

Scope

Acting as the representative in Switzerland under Arts. 14–15 DSG for controllers domiciled abroad whose Swiss-facing processing meets the Art. 14 DSG conditions: maintaining the record of processing and serving as the contact point for data subjects and the EDÖB. Advisory on, and coordination of, an EU Art. 27 GDPR representative where the same activity also targets the EU. The firm advises on the EU role; it does not act as the EU representative.

Target client

EU, US and other foreign controllers offering goods or services to, or monitoring, people in Switzerland and required to designate a Swiss representative.

Billing

Annual retainer

Scope

Role and risk classification (provider, deployer, importer), high-risk-system obligations (risk management, data governance, technical documentation, human oversight, post-market monitoring), general-purpose-AI duties, and the interplay with MDR/IVDR for AI medical devices. Conformity-assessment documentation and governance support as fixed-fee modules. The firm provides the legal documentation and coordination, not the technical conformity assessment.

Target client

Providers and deployers of AI systems with EU exposure; life-sciences and ICT companies placing AI/ML products on the EU market.

Billing

Monthly retainer + fixed-fee modules

Scope

Applicability and scoping assessments, governance and incident-reporting frameworks, ICT third-party and contractual requirements under DORA, product-cybersecurity obligations under the Cyber Resilience Act, and Swiss ISG touchpoints. Per-regime assessment modules; ongoing advisory as a retainer.

Target client

EU-regulated entities and their ICT providers under NIS2 / DORA; manufacturers of products with digital elements under the CRA; Swiss entities with ISG obligations.

Billing

Fixed-fee modules + monthly retainer

Scope

Review and negotiation of inbound or outbound commercial contracts (MSAs, DPAs, NDAs, SOWs, SaaS subscriptions); volume-based retainer with fair-use cap. Cyber and digital-resilience compliance (NIS2, DORA, CRA) is a separate service; see the Cyber & Digital Resilience tile.

Target client

Swiss SaaS scale-ups; mid-cap industrial companies digitalizing; ICT third-party service providers to financial institutions caught by DORA.

Billing

Monthly retainer

Scope

Legal basis for the secondary use of health data, consent and general-consent frameworks, biobank and research-database governance, anonymization and pseudonymization, and data-sharing arrangements (including for AI training) under the HFG, the HFV and the DSG.

Target client

Hospitals, research institutions and biobanks governing secondary use; companies sourcing health data for research or AI; sponsors structuring research-data sharing.

Billing

Monthly retainer + fixed-fee modules

Scope

Integrated regulatory function covering MDR/IVDR, EU AI Act and data protection across the lifecycle of software-as-a-medical-device, AI/ML diagnostic tools and cross-border telemedicine platforms: packaging the MDR/IVDR, EU AI Act and data-protection services into one mandate for digital-health products. Major filings (CE marking, AI conformity-assessment support) as fixed-fee modules.

Target client

Digital therapeutics makers; AI/ML diagnostic imaging and decision-support providers; cross-border telemedicine platforms in DACH.

Billing

Monthly retainer

Scope

License agreements (in-licensing or out-licensing), co-development and option deals, manufacturing supply and quality agreements, and distribution arrangements. Deal-anchored fixed fee for drafting and term-sheet work, hourly billing for active negotiation phases.

Target client

Swiss biotechs doing licensing deals with big pharma; Swiss-affiliate pharma and MedTech managing supplier and distribution chains.

Billing

Deal-based fixed fee + hourly negotiation

Scope

Counsel and co-counsel in commercial and investment-treaty arbitrations under Swiss Rules, ICC, DIS and other major rules, with subject-matter depth in life sciences disputes. Available for appointment as sole arbitrator, co-arbitrator or emergency arbitrator.

Target client

Parties to life-sciences-related disputes (distribution, licensing, supply, post-M&A); institutions seeking arbitrators with technical and linguistic range.

Billing

Hourly (counsel) or institutional schedule (arbitrator)

Scope

Independent legal review of internal compliance concerns (suspected kickback, off-label promotion, VITH violations); MedTech distribution-practices compliance audits; pre-acquisition compliance due diligence. Phase-based fixed-fee structure with negotiated caps.

Target client

Pharma affiliates responding to internal compliance concerns; MedTech companies under distribution-practices scrutiny; PE / strategic acquirers of CH or DE life sciences targets.

Billing

Phase-based fixed fee

Scope

A senior attorney embedded part-time as general counsel or specialized senior counsel: strategic legal oversight, contract-lifecycle management, regulatory compliance, board and executive support, and external-counsel coordination. Structured as a monthly retainer of defined days, scaling up during transactions or regulatory sprints. Distinct from tile 01's "Fractional Head of Regulatory Legal" tier, which is the regulatory-only retainer. How the model works.

Target client

Series A to C companies between general counsel, scaling into new markets, or needing Swiss / DACH legal presence without a full-time hire.

Billing

Monthly retainer; defined days per month, roll-forward