Six senior consultants.
One regulatory mind.
You don’t get a generalist team trying to cover everything. You get the specific specialist your case requires — each engaged independently based on what your situation actually demands.
Services for every regulatory need.
Five categories of expertise — from a one-time project to ongoing monthly support, or emergency activation when timing matters most.
- · Imminent FDA inspection
- · Warning letter response
- · Corporate audit prep
- · Quality crisis & recall
- · Gap analysis & diagnostic audit
- · Pre-inspection readiness
- · Mock & supplier audits
- · QMS review
- · QMS design & build
- · SOPs & documentation
- · CAPA & change control
- · IQ/OQ/PQ validation
- · Validation protocols
- · 483 & warning letter responses
- · Risk analysis & FMEA
- · Annual product reviews (APR/PQR)
- · GMP / cGMP training
- · Internal auditor certification
- · QA team onboarding
- · Executive workshops
From first call to first deliverable.
Four steps designed to make starting easy — with an urgent track for situations that cannot wait.
WhatsApp, email, or referral. The first message determines the path.
Consultative call, not a sales pitch. Honest assessment of whether we’re the right fit.
Hourly, fixed-scope, or monthly retainer. You choose what fits your rhythm.
Standard: 5–7 days. Urgent: 24–48 hours. First deliverable always ahead of schedule.
Regulated industries we know intimately.
Each regulated industry has its own language, its own regulators, its own pain points. Speaking that language fluently is what separates real expertise from generic consulting.
Industry not listed? Contact our team →
Three problems no one else solves together.
Consulting firms solve one. Staffing agencies solve another. We solve all three — with the speed of a specialist on demand and the depth of a full-time hire.
A senior QA hire with regulatory experience runs $80K–$100K plus benefits — a number that doesn’t fit a 30–100 employee company budget.
Senior QA professionals with regulatory experience are scarce. Open positions wait 4–8 months. The lost time has direct cost.
FDA inspection in three weeks. Warning letter with 30-day deadline. Corporate audit incoming. These don’t pause for hiring.
Three ways to work together.
Flexibility is the product. Every proposal includes all three — you choose the rhythm that fits your operation.
Senior expertise on specific issues, documents, or technical questions — without committing to a larger engagement. Billed in five-hour blocks.
Reserved hours each month for ongoing QA support — senior QA lead on retainer, available when you need them, without the overhead of hiring full-time.
We listen, identify what you actually need, and tell you honestly whether QA On Demand is the right fit — or recommend what is.
No cost · No obligation · Confidential
(939) 382-5554
migdalia@owgrp.com