Health & Life Sciences
Our perspective
Health and life sciences organisations operate under some of the strictest compliance requirements in the world. Their credibility rests on the quality of their clinical data, the rigour of their protocols and the strength of their regulatory governance.
Three points decide the timeline: market authorisation (MDR/IVDR, Swissmedic, EMA), the protection and sovereignty of health data, and dependency on a few clinical or regulatory experts. They return at every cycle: launching a device, scaling up, remediating after an audit, acquiring a player, preparing the divestment of a division or a company. Aegryn helps decide, then steers the project with your quality, regulatory, technology and leadership teams through to implementation.
Sectors covered
01Highly regulatedHealth & Pharmaceutical
Health data (Swiss FADP, GDPR), HL7/FHIR interoperability, Swissmedic and EMA authorisations, supply chain, divestment of divisions and R&D assets.
02GrowthHealthTech & MedTech
Diagnostic AI, MDR/IVDR compliance, health data, interoperability, takeover by an industrial player or a fund.
03R&DBiotech, laboratories & CROs
Clinical research, proprietary protocols, patents and datasets: financing, industrial partnerships, licensing.
Our applied expertise
From product to market: strategy, access and business model
Product positioning, choice of markets and authorisation routes, business model (reimbursement, licensing, industrial partnerships), R&D governance, acquisition thesis. Deliverable: four-test grid applied to the options, and a 12-18 month plan.
Regulatory compliance & quality
Mapping of applicable requirements (MDR/IVDR, Swissmedic, EMA, AI Act for diagnostic AI, Swiss FADP, GDPR), quality management system, vigilance, preparation for audits and inspections. Deliverable: "applies now / soon / not concerned" map and prioritised remediation plan.
Health data, interoperability & sovereignty
Sovereign HealthTech architecture hosted in Switzerland or the EU, HL7/FHIR integration, patient data governance, critical providers and exit plan, governance of diagnostic AI models. Custom tools only when the market does not offer them. Deliverable: reversibility test and quantified trade-off.
Regulatory experts, quality & scientific leadership
Regulatory affairs and quality officers, pharmacovigilance, medical directors, clinical data scientists, succession of the scientific founder. Deliverable: job description, shortlisted profiles, succession plan.
Acquisition, carve-out & divestment of health assets
Review of a target before the offer: transferable authorisations and certificates, ownership of patents and datasets, patient consents, supplier contracts, dependency on key researchers. Integration, division carve-out or divestment. CIFSO 5000 certification remains available in support. Deliverable: proposed treatment for each point (price, warranty, suspensive condition) and a milestone-based integration or separation plan. Execution remains with your investment bank and your lawyers.
Available individually, or combined into a programme we steer.
How we support our clients
Three typical profiles, three concrete situations.
Growing MedTech & HealthTech: Launch and Growth cycles
“You have developed a medical device with diagnostic AI. CE marking or Swissmedic authorisation, data hosting, first quality hires: each requirement has its counterpart, and an industrial player is starting to take an interest.”
What we steer
- Choose the authorisation route and timeline (CE marking, Swissmedic, then next markets) → written trade-off, including what to give up.
- Secure platform and data: code ownership, hosting, reversibility → position note and clauses to fix.
- Select regulatory affairs and quality officers → job descriptions and shortlisted profiles.
Pharmaceutical groups & laboratories: Restructuring and Succession cycles
“You are divesting a division or outsourcing an R&D asset. Patents, clinical data and supplier contracts are scattered, and the acquirer expects a solid data room and a controlled data transfer.”
What we steer
- Inventory what goes with the asset: patents, datasets, contracts, authorisations → inventory and proposed treatment for each item.
- Govern sensitive data transfers: consents, cross-border flows → transfer plan validated by your data protection officer.
- Plan the separation of teams and systems → milestone-based separation plan.
Acquiring funds & industrials: Acquisition (Takeover) cycle
“You are assessing a promising HealthTech target whose regulatory compliance and data quality are difficult to evaluate. Before signing, you want an independent read that goes beyond the financial audit.”
What we steer
- Screen the target: authorisations, data quality and sovereignty, intellectual property, key people → proposed treatment for each point: price, warranty, suspensive condition.
- Prepare the integration → milestone-based integration plan.
- Organise retention of researchers and key experts → 24-month retention plan.
Transaction execution remains with your investment bank or your lawyers. Aegryn does not provide medical advice and does not substitute for your regulatory officer.
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