We bridge the gap between financial potential and FDA regulatory reality. We function as an extension of your investment team, validating your thesis before the deal closes and accelerating your portfolio's path to exit.
Forensic Regulatory Diligence
We uncover what the pitch deck hides. Our deep-dive audits of clinical datasets and correspondence substantiate scientific claims to de-risk your entry.
Launching products involves several crucial assumptions for success...
Is the timeline for testing and approval realistic?
How much and what kinds of tests, data, modeling, are sufficient and realistic for FDA approvability?
Does the evidence back up your investment?
Are you overlooking something?
Let our integrated expertise work for you.
Carry out due dilligence before and after investment for confidence and closure on your decision. Get expert advice for what to look for in both in current and future endeavers. (Is this product a Go or No-Go?)
Examine potential blindspots in product viability:
- Timeline; Cost of Delays
- Marketability
- Competition and Intellectual Property
- User Needs
- Pricing & Coverage Coding Reimbursement
- FDA Approvability
Insider Perspective
Our team of interdisciplinary experts created the internal training materials for FDA Medical Officers and Pre-Market Reviewers that are still used to this day.
SUPPORT AT THE MOMENTS THAT CREATE VALUE
Assess the Risk
Diligent regulatory risk evaluation before you invest, assessing approval pathways, evidence packages, quality systems, compliance, and market access considerations.
Protect the Timeline
Realistic strategy formulation, guiding and supporting efficient evidence generation, timely submissions, and productive FDA engagements. Maintain a projectable time-to-market and proactively avoid delays.
In the biotech sector, delays are measured in millions. For a blockbuster asset, every single day on the U.S. market can generate at least ~$1M in profit. Taking an extra 60 days to get FDA approval could cost a portfolio company ~$60M in lost revenue [1].
ONE INTEGRATED INVESTMENT LENS
Approvability
FDA Pathway - Least burdensome approach, precedents, submissions, and labeling.
Evidence
Clinical and Market Access - Endpoints, RWD/RWE, fit-for-purpose, reimbursement, and adoption.
Execution Readiness
Quality and Compliance - Submissions, GxP, quality systems, inspections, and remediation.
We identify what’s holding development back and build a practical recovery plan, prioritizing corrective actions, FDA engagement, and additional evidence. We outline timelines and costs to help you decide whether to invest further.
Utilize regulatory remediation; addressing holds, CRLs, inspection findings, and evidence gaps to restore asset value and reestablish a path to approval.
Gaps can be present in a plethora of ways for products attempting regulatory approval. Allow our team of diverse experts to uncover any potential gaps in:
- Evidence
- Testing
- Clinical Perspective & Bench perspective
- Timeline & Projections
- Logic for Trials and Testing
- Plausibility, Scalability, Marketability...
What is preventing your investment from approval?
Our team helps to address regulatory challenges at any stage of development and provides further advisement on your investment.
Strategic Information
- Feasibility & Modeling: We validate the use of novel technologies like in-silico modeling, AI/ML-based tools, and Real World Data/Evidence (RWD/RWE) to ensure the proposed clinical path is viable and cost-efficient.
- Lifecycle Management: We provide full-service support for clinical study design and oversight to ensure your portfolio companies generate submission-ready data.
REGULATORY RISK IS INVESTMENT RISK.
Schedule a confidential regulatory investment review today.
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