Getting the filing right the first time
Pre-IND strategy, briefing packages, and CMC alignment with your manufacturing partners — coordinated early, not reconciled under a filing deadline. We also assess readiness for the proposed Expedited IND pathways under Operation TrialBlazer, where relevant to your program.
Dose-escalation designs built for the modality
Bayesian and rule-based dose-escalation designs, clinically grounded DLT definitions, and dose-optimization strategy aligned with Project Optimus expectations — not a template pulled from a different modality's playbook.
Physician-led, amendment-resistant protocols
Population, endpoints, and eligibility criteria written by a physician who has to defend them at a Type B meeting — not assembled from a boilerplate template. Optional ICH M11 structured-protocol authoring for programs standardizing ahead of the requirement.
Where this shows up
Roughly a quarter of clinical holds trace to avoidable CMC and quality gaps, and amendment-prone protocols are one of the three places sound science dies in Phase 2/3 — alongside population mismatch and enrollment infeasibility. Getting the protocol right the first time is the single highest-leverage document in the program.
Read our whitepaper on trial design →Navigated, not just defined
Every expedited program comes with a real application and a real agency conversation behind it — not a glossary entry.
Fast Track & Breakthrough Therapy
Designation strategy built around the actual unmet-need and preliminary-evidence case your data supports.
RMAT
Regenerative Medicine Advanced Therapy designation for cell and gene therapy programs, including the alignment meetings it unlocks.
Accelerated Approval
Surrogate-endpoint strategy and the post-marketing confirmatory-trial commitments that come with it, planned from day one.
Real-Time Oncology Review (RTOR)
Iterative, rolling data submission ahead of a formal filing — coordinated so your data package is ready when the agency asks for it.
Project Orbis
Concurrent international review coordination across participating health authorities.
Orphan Drug & Rare Pediatric Disease
Designation applications and Priority Review Voucher strategy for rare-cancer and hematologic-malignancy programs.
Prepared for the meeting, not just the briefing book
Pre-IND, Type B, and Type C meeting preparation — briefing packages, anticipated-question rehearsal, and response strategy built by people who have sat on both sides of the table.
- › Briefing book authored to the question the agency will actually ask
- › Mock Q&A rehearsal before the real meeting
- › A response strategy ready before the minutes arrive
"We had the briefing book. We didn't have an answer for the question they actually asked."
The gap between a compliant briefing package and a meeting that goes your way.
The submission holds up because it was built to
Red-team review
A comprehensive risk assessment of your submission before filing — gaps identified, questions anticipated, before the agency finds them first.
Integrated safety narrative
One coherent safety story across every module — not a patchwork assembled by whoever wrote each section.
Mock inspection
A rehearsal of the inspection question — with documentation gaps found and closed before an actual inspector asks.
Solid tumor and hematologic malignancy depth, across the modalities that matter most
Our principals have led development programs spanning solid tumors and hematologic malignancies, with particular depth in the novel modalities where the regulatory and safety questions are hardest.
See expertise by modality →Educate · Evaluate · Execute
Regulatory pathway briefing
Which expedited programs actually fit your data and timeline — for your board and your regulatory team.
IND or BLA red-team
A bounded, fixed-fee risk assessment of your submission — gaps, anticipated questions, and a remediation plan.
Protocol & signal definitions
Ongoing authorship and agency-interaction support, through submission and beyond.
Book an IND or BLA red-team.
Bring us the submission, the pathway question, or the meeting you're preparing for.