FDA Regulatory & Recall Management Consulting
Senior-level regulatory guidance for food, supplement, and medical device companies — delivered directly by a specialist who has managed recalls at enterprise scale.
Expertise across
What I do
From your first food safety plan to a live FDA recall, every engagement is handled directly — no junior teams, no handoffs.
End-to-end recall program design, live recall coordination, FDA effectiveness checks, and 806 documentation — grounded in direct enterprise-scale recall experience.
Preventive Controls Rule implementation, HARPC food safety plans, FSVP foreign supplier verification, and annual review support for manufacturers of every size.
QMS design and gap assessment, CAPA program build-out, complaint handling SOPs, and audit readiness for FDA, USDA, BRC, and SQF.
510(k) pre-submission planning, predicate selection, substantial equivalence analysis, Design Controls, and post-market surveillance for Class I–III devices.
cGMP audit preparation and remediation, 21 CFR Part 111 compliance, structure/function claim review, label accuracy, and adverse event reporting setup.
Mock FDA audits, 483 response strategy and drafting, warning letter remediation, and corrective action documentation. Know where you stand before an investigator does.
Who I serve
Deep, hands-on experience across the full range of FDA-regulated product companies.
Manufacturers, co-packers, specialty CPG brands, and importers navigating FSMA, USDA FSIS, and GFSI scheme requirements.
Nutraceutical and private-label manufacturers, contract manufacturers, and DTC brands managing DSHEA, 21 CFR 111, and labeling.
Class I–III makers, IVD developers, and SaMD companies navigating 510(k), De Novo, PMA, and post-clearance obligations.
Why Arcis
Most consultants sell you their time. I bring the judgment of someone who has actually run recalls when the stakes were real.
You work with the same specialist from first call to final resolution. No junior staff, no escalation chains, nothing lost in translation.
Every recommendation comes from running recall programs, deploying enterprise quality systems, and navigating real FDA interactions — not from reading the regulations.
Most growing regulated companies can't justify a full-time regulatory director. Arcis gives you that senior function on demand, at a fraction of the cost.
Arcis is building AI-assisted compliance tools to accelerate documentation, trend analysis, and audit prep — modern regulatory work, done modern.
How it works
A 30-minute conversation to understand your situation, risks, and goals. No charge, no commitment.
A structured review of your current compliance posture against the FDA, USDA, or GFSI requirements that apply to you.
A prioritized action plan with clear deliverables, timelines, and outcomes — scoped to your budget and stage.
Hands-on implementation: documentation, SOPs, training, audit prep, or live recall coordination.
Book a free 30-minute discovery call and walk away with clarity on your biggest compliance risks — whether or not we work together.