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Resources for Investors
Apsis Consulting Group
Tel. 475-237-7994
54 State Street, STE 804 #8573
Albany, New York 12207
Regulatory Diligence for Investors
Independent, time-boxed assessments of FDA pathway feasibility, evidence sufficiency so your investment decisions are faster and better-informed.
Flexible Diligence Models to Fit Your Target
De-risk MedTech deals with an independent, time-boxed regulatory read.
Pathway, evidence, and QMS risk distilled into an IC-ready analysis and costed timeline.
Venture Growth & Equity
Objective view of regulatory risk and execution readiness across a single asset or portfolio.
Get a clear picture of downside scenarios, remediation and exposure
Boards
Buy-side regulatory diligence for tuck-ins and platform acquisitions.
Surface integration risks, hidden compliance debt, and post-close RA/QA workstreams before you sign.
Acquisitions
Ready for FDA Clarity?
Asset | Snapshot Diligence | Core Diligence | Deep Diligence |
|---|---|---|---|
Classification | ✓ | ✓ | ✓ |
Pathway | ✓ | ✓ | ✓ |
Regulator Plan | ✓ | ✓ | ✓ |
Timeline | ✓ | ✓ | ✓ |
Pre-Clinical Tests | - | ✓ | ✓ |
Device Specific Requirements (AI/ML, SaMD, Cyber) | - | ✓ | ✓ |
Clinical Plan | - | - | ✓ |
Submission Readiness | - | - | ✓ |
Manufacturing Readiness | - | - | ✓ |
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