How It Works

From First Contact to FDA Clearance

Every engagement follows a structured roadmap — here's what working with ADB CRO looks like.

Phase 1

Discovery Call

Free 30-minute call with Andre. We assess your device, regulatory situation, and goals. You leave with clarity — no obligation required.

Scheduled within 48 hours

Phase 2

Regulatory Strategy Document

Device classification analysis, pathway recommendation (510(k), De Novo, PMA, IDE), predicate landscape, and a written regulatory strategy document delivered to you.

1–2 weeks post-kickoff

Phase 3

Testing & Gap Analysis

Identify all testing requirements, review existing data, and build a testing gap action plan with vendor recommendations.

2–4 weeks

Phase 4

Submission Preparation

Hands-on preparation of all submission sections — Device Description, Predicate Comparison, Performance Testing Summaries, Substantial Equivalence, and supporting documentation.

4–12 weeks (submission dependent)

Phase 5

FDA Submission

Final QC, eCopy preparation, CDRH Direct submission, and confirmation of FDA receipt. We monitor the review queue and maintain contact with FDA as needed.

FDA Review: 90–180 days (510(k) typical)

Phase 6

FDA Response Management

When FDA issues Additional Information requests or Deficiency letters, we respond quickly and strategically — resolving FDA questions in a single cycle whenever possible.

Response within 21 days of FDA request

Phase 7

FDA Clearance

Device cleared. We provide the clearance order summary, post-market surveillance recommendations, and ongoing QMS support to keep you compliant.

You are cleared to market

Engagement Models

How We Work Together

Flexible engagement structures designed to fit your stage, budget, and needs.

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Project-Based

Scoped deliverable with fixed timeline and milestones. Ideal for single submissions, gap analyses, or regulatory strategy documents.

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Retained Advisor

Ongoing monthly retainer for continuous regulatory support — strategy reviews, FDA correspondence, QMS oversight, and direct access to Andre.

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Emergency Response

Immediate mobilization for FDA 483 or Warning Letter situations. Hourly or day-rate with 24-48 hour response SLA.

How Our FDA Regulatory Consulting Process Works