FDA Pathway Consulting
Pick the wrong FDA pathway and you can cost a program years. We map your product to the fastest viable regulatory route — IND, IDE, 510(k), De Novo, BLA, Section 505, or combination — and build the evidence story to support it.
Pathway is a strategic decision, not paperwork.
IND or IDE. 510(k) or De Novo. BLA or Section 505. Drug, device, biologic, or combination. Each pathway carries its own evidence requirements, timeline, and risk profile — and the wrong choice locks a program into the wrong studies for years. Our FDA pathway consulting starts with the product, the indication, and the commercial goal, and works backward to identify the fastest viable pathway and the smallest evidence package that supports it.
Product Classification
Drug, device, biologic, or combination — the foundational classification that drives every downstream pathway choice.
Pathway Analysis
510(k) vs De Novo vs PMA for devices. IND vs Section 505 for drugs. BLA route selection for biologics. The trade-offs in plain terms.
Predicate & Precedent
For device pathways, predicate identification and substantial-equivalence framing. For drugs, precedent and bridging analysis.
Pre-Submission Strategy
Pre-IND, Pre-Sub (Q-Sub), Type B/C meetings — when to ask, what to ask, and how to prepare for the answer.
Scenario Planning
Where multiple pathways are viable, decision-tree analysis tied to time, cost, and downstream label or claim implications.
Cross-Jurisdiction
FDA, EU MDR, Health Canada, PMDA — pathway alignment across regulators where global launch matters.
FDA pathway consulting, before the wrong path is chosen.
Pre-IND / Pre-IDE Programs
Founders making the pathway choice that will shape their next two years of evidence.
Combination Products
Drug-device, biologic-device, or diagnostic-therapeutic combinations where pathway is genuinely ambiguous.
Pathway Pivots
Programs reconsidering their pathway after FDA feedback, a clinical hold, or a market-strategy shift.
Diligence & Investors
Investor-side pathway review as part of due diligence on an early-stage asset.
From product profile to FDA-aligned pathway.
Product Review
Understand the product, intended claims, target market, and commercial goal.
Pathway Options
Identify the viable pathways and the evidence each requires.
Trade-off Analysis
Time, cost, risk, and downstream label implications — explicit comparison.
FDA Engagement
Pre-submission strategy and meeting preparation to validate the chosen route.
Standards we work in.
Map your FDA pathway.
A focused 4–6 week engagement that converts pathway ambiguity into a defensible regulatory choice.
Regulatory Pathway + Risk Register Sprint
- Pathway options analyzed with explicit time/cost/risk trade-offs
- Predicate or precedent analysis where applicable
- Pre-submission meeting strategy outline