for Life Science Investors
Medical Devices – In-vitro Diagnostics – Pharma – ATMPs – SoHO
Independent R&D, Quality and Regulatory review of the data room for VC, PE and corporate investors
Why regulatory due diligence matters
In regulated life sciences, a company’s value depends on whether its product can actually reach the market. A gap in the technical documentation, the quality system or the clinical evidence can delay certification or approval by years, or stop it altogether.
These risks are rarely visible in a pitch deck. They sit in the design history file, the biological evaluation, the batch records and the regulatory roadmap. We read the data room with the eyes of a Notified Body and a regulator, and translate what we find into clear findings for your investment decision.
We assess whether the science behind your target will stand up to MDR, IVDR, GMP and the new SoHO Regulation, before you sign.
Four product areas, one integrated view
Medical Devices & IVDs
- Classification and MDR/IVDR certification strategy
- Technical documentation against the GSPR
- Clinical and performance evaluation: will it hold up with the Notified Body?
- Software and SaMD
documentation
Materials & Biological Safety
- Biological evaluation (ISO 10993-1)
- Chemical characterization and extractables & leachables (ISO 10993-18)
- Toxicological risk assessment (ISO 10993-17)
- Substance-based devices and polymers
ATMPs
- Classification as gene therapy, cell therapy or tissue engineered product
- GMP readiness and quality system
- Scalability from lab process to commercial manufacturing
- Starting and raw materials of biological origin
Substances of Human Origin
- Readiness for the SoHO Regulation (EU) 2024/1938
- Traceability from donor to recipient
- Quality systems for procurement and processing
- Donor and recipient safety
Bridging R&D, Quality and Regulatory
Start-ups often develop excellent science but underestimate what regulators and Notified Bodies expect.
We look at exactly the interfaces where that becomes expensive.
R&D-to-QA gap
Was development done under an ISO 13485 or GMPcompliant quality system from the start? An incomplete design history file can mean repeating development work.
Regulatory strategy fit
Do the intended purpose, classification and clinical endpoints support the planned certification or approval route, or will the evidence fall short?
Scale-up and tech transfer
A process that works in the lab must be validated, reproducible and affordable at commercial scale, including supplier and raw material control.
From red flags to solutions
Red Flag Report
A focused review of the data room with prioritized findings, their impact on timeline and cost, and the questions to put to management. Delivered within [10–14] working days, depending on scope.
Closing the gaps
Hands-on support after the investment: interim QA/RA management, QMS remediation towards ISO 13485 certification, preparation for Notified Body audits, and PRRC and EU Authorized Representative services.
Science and regulation in one hand
Led by a chemist (Dr. rer. nat.) with nearly 30 years of experience in R&D, Quality Assurance and Regulatory Affairs, we understand both the science in the lab notebook and the expectations of authorities and Notified Bodies.
We have built quality systems for start-ups up to certification and act as PRRC and EU Authorized Representative ourselves, so our findings are grounded in day-today regulatory practice.
Regulatory frameworks we work with
Who we work for
- Venture capital and private equity funds with a life science focus
- Corporate venture arms of medtech, pharma and chemical companies
- M&A law firms that need a technical expert opinion
- Founders preparing their company for investment
Planning a transaction?
Contact us for a confidential exploratory call about your upcoming target screening or live due diligence timeline.