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AI implementation partner for regulated industries

We assess your process.
We design your tools.
We make it compliant.

RxQMSR works inside life sciences and regulated manufacturing environments to identify where AI creates value, design the right toolset for your operation, and implement it to FDA and ISO standards — so it survives an inspection.

Start a Consultation How our engagements work
We serve
Medical Device Manufacturers Pharma & Biotech Supplement & Nutraceutical Brands PE-Backed Life Sciences Portfolios
What our clients typically save
$18K
per month
Medical device QA labor
$40K
per month
Pharma batch review
30d
to live solution
Supplement fastest engagement
86%
audit prep cut
Contract mfg · 2 wks → 2 days
Regulatory Alert April 2026 — FDA issued its first AI-related warning letter citing deficiencies in AI-assisted manufacturing processes under 21 CFR Part 211. If your facility uses AI in any regulated workflow, the compliance window is now. Read our analysis →
What we do

We don't sell software.
We solve your compliance problem.

Every engagement begins with a deep review of your processes, your regulatory obligations, and your operational constraints. From there, we identify and design the right AI tools for your environment — then build, validate, and implement them to the standard your industry requires.

01 — Compliance Consulting
Process Review & Gap Assessment
We map your current workflows against your regulatory obligations — 21 CFR, ISO 13485, cGMP — and identify exactly where AI creates value and where it creates risk. You leave with a prioritized opportunity map.
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02 — Tool Architecture
AI Toolset Design
We design the specific AI tools, agents, and workflows suited to your environment and your compliance requirements. No generic stack — every solution is architected for your operation and your CFR obligations.
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03 — Implementation
Validated Deployment & QMS Integration
We build and deploy your solution with full validation documentation — URS, IQ/OQ/PQ, change control — and integrate it into your existing quality system so it runs the way FDA expects it to.
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How an engagement works
Four phases. One partner. Full regulatory coverage.
Phase 01
Discovery
We review your processes, your regulatory environment, and your current AI use — or absence of it. We identify the highest-value, lowest-risk opportunities specific to your facility.
Phase 02
Architecture
We design the right toolset for your operation — specific AI agents, integrations, and workflows matched to your CFR obligations and your team's actual capacity.
Phase 03
Implementation
We build, configure, and deploy your solution. Validation documentation — URS, IQ/OQ/PQ, SOPs — is produced in parallel so nothing is retrofitted after the fact.
Phase 04
Compliance
Ongoing change control, revalidation support, and regulatory monitoring as your AI environment and the regulatory landscape evolve. We stay in as your compliance partner.
Why RxQMSR

Most AI consultants don't know your regulations.
Most compliance firms don't know AI.

RxQMSR was built specifically for the intersection — firms that need both deep regulatory fluency and hands-on AI implementation experience, in a single engagement team.

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Regulatory-first by design Every tool we design is scoped against your specific CFR obligations before a line of code is written. Compliance is not an afterthought.
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No generic stack We don't sell a platform or push a preferred vendor. We identify and design what's right for your environment, then build it.
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Validation documentation included URS, IQ/OQ/PQ, SOPs, and change control records are produced as part of every implementation — not sold separately.
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Built for the mid-market We work with the facilities that large AI vendors overlook and compliance firms overcharge — PE-backed portfolios, growing device companies, scaling supplement brands.

Let's start with your process.

Book a consultation. We'll review your current workflows, identify your compliance gaps, and tell you exactly where AI creates value in your operation.

Start a Consultation No commitment · 45-minute session