Health & Life Sciences
Our perspective
Health and life sciences organisations operate under some of the strictest compliance requirements in the world. Their value lies in their clinical data capital, proprietary protocols and the strength of their regulatory governance.
CIFSO 5000 Certification applies with granularity adapted to these constraints: documenting the value of health data, the robustness of quality processes and the transferability of the organisation ahead of a sale, financing or industrial partnership.
Sectors covered
01Highly regulatedHealth & Pharmaceutical
GDPR/HIPAA data, HL7/FHIR interoperability, EMA compliance, supply chain and clinical IP.
02GrowthHealthTech & MedTech
Diagnostic AI, MDR/IVDR compliance, health data, interoperability and M&A valuation.
Our applied expertise
CIFSO 5000 Certification
Certified documentation of the value of clinical data, proprietary protocols and quality governance — enforceable against an industrial acquirer, an EMA regulator or a pharmaceutical partner.
Technology Advisory
Sovereign HealthTech architecture, MDR/IVDR compliance, HL7/FHIR integration, patient data governance and security of critical health systems.
Custom Solutions
Clinical management platforms, diagnostic AI tools, interoperability systems and secure data rooms — designed for healthcare regulatory constraints.
M&A Advisory
Structuring and supporting pharma and HealthTech deals, valuing clinical IP and diagnostic algorithms, preparing due diligence for industrial acquirers or funds.
How we support our clients
Three typical profiles, three concrete situations.
Growing MedTech
“You have developed a medical device with diagnostic AI. A pharmaceutical company is interested in an acquisition, but requires complete MDR/IVDR documentation and certification of the value of your algorithms before engaging its due diligence teams.”
What we solve
- Prepare a defensible M&A dossier including certification of diagnostic AI algorithms
- Document MDR/IVDR compliance in an enforceable way for an industrial investor
- Structure IP value (patents, clinical datasets) as a certifiable and transferable asset
Pharmaceutical groups
“You are divesting a division or outsourcing an R&D asset. Your patents, clinical data and supplier contracts are scattered. The acquirer requires a solid data room and data governance documentation that withstands an EMA audit.”
What we solve
- Document and certify the value of proprietary patents and clinical datasets
- Govern sensitive data transfers in the context of an asset sale
- Prepare a certified data room defensible against pharmaceutical due diligence
HealthTech investors
“You are assessing a promising HealthTech target whose regulatory governance and data quality are difficult to evaluate. Before signing, you need an independent assessment that goes beyond traditional financial audits.”
What we solve
- Verify the MDR/IVDR and health GDPR regulatory robustness of a target before investing
- Assess the quality and sovereignty of patient data as a value asset
- Quantify intangible assets (clinical IP, algorithms, protocols) with a certified framework
Publications associées
Toutes nos publications
Certification
What makes a tech asset truly certifiable?
The objective criteria that distinguish a certifiable asset from one requiring a remediation plan, according to the Aegryn Grade protocol.
Certification
Independent certification before SaaS sale: why it has become indispensable in 2026
SaaS assets independently certified before sale sell for 25–40% more and 3× faster. Anatomy of the Aegryn Grade certification process and its impact on negotiation.
Verticals
Health & Life Sciences: intangible asset value under regulatory pressure
In health and life sciences sectors, the real value of an organisation lies in its clinical data, protocols and governance. Analysis of certification and transfer issues for European HealthTech and pharma players.
CIFSO 5000 Certification
Get your organisation assessed and obtain a defensible independent certification.
