---

name: reg-strategy
description: "Build a precedent-grounded regulatory strategy for a new product — so you know exactly what the agency will ask before they ask it."

/reg-strategy

Regulatory naivety delays products by years. Not because companies skip steps — but because they submit with evidence gaps they didn't know were gaps, or chose a pathway without benchmarking the actual precedent, or waited for a Complete Response Letter to learn what a Type C meeting would have told them for free. This skill forces a systematic review of analogous submissions, maps your evidence gaps against regulatory expectations, and produces a strategy that survives the agency's first response.

Product Definition

• Exact product description — mechanism of action, indication, patient population, route of administration
• Proposed regulatory pathway (510(k), PMA, NDA, BLA, De Novo, EUA — or equivalent in EU/other jurisdictions)
• What makes this product different from what already exists? (This is the agency's first question)
• What is the risk profile — and what is the worst-case failure mode for a patient?
• Any combination product or software component (SaMD) that triggers additional regulatory frameworks?

Precedent Analysis — 4-5 analogous submissions:

For each precedent:

• Submission ID, product, indication, applicant, submission date, outcome
• Pathway chosen and why it was appropriate
• Study types and sample sizes accepted
• What the agency required that was non-obvious from guidance documents?
• Any Complete Response Letters or additional information requests — what triggered them?
• Time from submission to clearance/approval

Evidence Gap Analysis

• What does the agency's guidance document say is required vs what your current data package contains?
• What do the precedent submissions suggest is required beyond the guidance? (Guidance documents are always behind current agency practice)
• For each gap: what study/test closes it, estimated timeline, estimated cost, and can it be done in parallel with other activities?
• Which gaps require novel study designs (no established protocol)?

The Critical Path

• Submission sequence — pre-submission meeting → study execution → IND/IDE if applicable → final submission
• Early engagement opportunities: Pre-Sub (FDA), Scientific Advice (EMA), Type B/C meeting requests
• What specific questions to bring to the pre-submission meeting — vague questions get vague answers
• Timeline from today to submission, realistic vs optimistic scenario

The One Gap That Could Delay 12+ Months

• Which evidence gap, if not addressed early, becomes a Complete Response Letter 9 months after submission?
• What is the study type that takes longest to execute?
• What is the agency's track record on this evidence type — have they recently raised the bar?

Risk Register

• What is the agency most likely to disagree with in your proposed indication?
• Are there any pending guidance documents or recent Advisory Committee discussions that could shift requirements?
• Competitive submissions that might set a new precedent before yours arrives?

Rules

1. Precedent analysis is mandatory. Guidance documents describe the floor, not the ceiling — recent precedents describe the actual expectation.
2. Every evidence gap must have a named owner and a timeline. "We'll figure it out later" is how delays happen.
3. Pre-submission meetings are almost always worth requesting. Document the specific questions you will ask.
4. Combination products and SaMD components must be flagged immediately — they add 6-18 months minimum.
5. Distinguish between what the agency requires and what they prefer. Both matter, but they're different risks.
6. Strategy documents must be updated after every agency interaction. A static strategy is a stale strategy.

The output of this skill is a regulatory strategy brief: pathway rationale, evidence package status, gap closure plan, submission timeline, and the one risk that could delay approval by a year if not addressed in the next 90 days.