Technical due diligence · Commercialization assessment
Independent scientific, regulatory, and commercial assessments of diagnostic assays, technology portfolios, and companies — for investors, acquirers, and the teams seeking their support.
Why ResearchDx
ResearchDx provides expert assistance with questions about marketability, funding sources, commercial partners, patenting and other protection methods, new business startup considerations, licensure, regulatory requirements, and reimbursement — including local coverage determinations (LCDs), PLA and CPT coding, and MolDX applications.
Because we operate a CLIA-certified, CAP-accredited laboratory and support FDA submissions every day, we review an assay the way a regulator, a payer, and a laboratory director would — and tell you plainly what stands between the technology and the market.
Two kinds of assessment
Investors and acquirers use technical due diligence to understand what they are buying. Developers use a commercialization assessment to plan the path to market.
Technical due diligence (TDD) examines an assay, technology portfolio, or organization from a technical perspective: its products, technical infrastructure and architecture, product roadmap, services, practices, and staffing. It is usually carried out before major corporate events.
A structured look at what it will take to bring your product to market — regulatory, reimbursement, laboratory, and commercial — so you can plan, budget, and raise with confidence.
What we evaluate
Each assessment is scoped to your question, drawing on the areas below.
How it works
We agree on the decision you need to make, the questions that matter, the documents to review, and the deadline. Work begins under NDA.
Our scientists, regulatory, and laboratory experts review the data room, interview the technical team, and visit the site when needed.
You receive a written assessment of strengths, risks, and gaps, with recommendations, and a call to walk through the findings.
What you receive
Diligence often runs on a closing date. Contact us early and we will tell you what can be covered in the time available.
Tell us about the assay, technology, or company you are evaluating, and your timeline.