SERVICES FOR INVESTORS
ACCELERATING RETURNS. NAVIGATING COMPLEX LANDSCAPES.
Financial metrics only tell half the story. FDA regulatory risk is one of the most consequential variables in shaping asset value.
The Speed Advantage
The Speed Advantage
The Speed Advantage
We specialize in identifying expedited strategies to maximize asset valuation and shorten timelines.
Getting "Unstuck"
The Speed Advantage
The Speed Advantage
We intervene when assets stall. We deploy senior expertise to resolve clinical holds and negotiate directly with FDA review divisions to get the product moving again.
Former FDA & Industry Leaders
Former FDA & Industry Leaders
Former FDA & Industry Leaders
Our team is comprised of former FDA senior officials, industry veterans, and academic stakeholders with 250+ years of combined insight.
Teaching the Regulator
Former FDA & Industry Leaders
Former FDA & Industry Leaders
We created internal training materials for FDA Medical Officers and Pre-Market Reviewers that are still used to this day.
Proven Outcomes
Former FDA & Industry Leaders
Proven Outcomes
We helped over a dozen companies secure marketing authorizations, including the first-ever FDA Breakthrough Device Designation (BDD) for treating Alzheimer’s disease.
SERVICE OFFERING FOR THE INVESTOR
The Strategic Advantage: Intelligence & Policy
Success belongs to those astute enough to keep pace with rapid advancements in FDA regulatory policy. We help your portfolio companies leverage new and novel policies to their advantage, utilizing these shifts to expedite approvals and reduce clinical burdens and associated costs.
Forensic Regulatory Diligence (Pre-Deal)
We uncover what the pitch deck hides. Our deep-dive audits of clinical datasets and correspondence substantiate scientific claims to de-risk your entry.
Strategic Intervention (Post-Deal)
- 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.