Transforming Science into Strategy
& Strategy into Impact
We help biopharma and medtech innovators navigate clinical, regulatory, and market challenges to accelerate innovation and improve patient outcomes
Exclusively with Seasoned BioPharma & MedTech Veterans
Featured Case Study
Rare Pain Condition Gets FDA Reprieve
A biotech developing rare metabolic bone disease faces regulatory misalignment with FDA pain guidelines. We crafted an alternative pathway, engaged the FDA, and reduced the program two Phase 3s to one, saving millions and accelerating time-to-patient.
Medical Affairs
Navigating the First Launch
Actionable Medical Affairs blueprint aligning clinical market access and medical functions.
Clinical Development
Beyond the Protocol
Patient + payer input to improve recruitment and real-world relevance.
Market Access
De-risking Market Access
Pricing strategy + payer roadmap for a one-time gene therapy.
Real World Evidence (RWE)
Driving Credibility for MedTech
Publication strategy powering adoption and reimbursement conversations.
From profile to patient.
Covering all areas of drug/device lifecycle:
Research
Development
Submissions
Commercialization
