REGULATORY QMSR replaces 21 CFR Part 820 — is your quality system ready? Check your gaps free →
Enterprise-grade Security
No implementation required
GDPR & CCPA Compliant
Fractional QA/RA

Senior expertise on demand

Quality and regulatory expertise when you need it, without the full-time cost.

Get fractional support
Support

What's included

Day-to-day QMS support

CAPA review, NCR assistance, change control guidance, document review.

Regulatory strategy

Submission pathway guidance, regulatory intelligence, market access planning.

Team mentoring

Develop your internal team's QA/RA capabilities over time.

Audit support

Preparation, attendance, and response assistance for audits and inspections.

Pricing

Monthly plans

Light
10 hours/month
$2,000 per month
For companies with occasional QA/RA questions and light support needs.
  • 10 hours per month
  • Email and call support
  • Document review
  • 48-hour response time
  • Unused hours don't roll over
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Standard
20 hours/month
$3,500 per month
For growing companies with regular QA/RA needs.
  • 20 hours per month
  • Dedicated consultant
  • Weekly check-in call
  • 24-hour response time
  • Up to 5 hours roll over
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Dedicated
40 hours/month
$6,000 per month
Like having a part-time QA director without the full-time cost.
  • 40 hours per month
  • Dedicated senior consultant
  • Twice-weekly calls
  • Same-day response
  • Up to 10 hours roll over
  • On-site visit included (quarterly)
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Comparison

Why fractional makes sense

Factor Full-time hire Fractional
Annual cost $150,000 - $250,000+ $24,000 - $72,000
Experience level What you can afford Senior-level guaranteed
Time to onboard 3-6 months to hire + ramp Start immediately
Flexibility Fixed commitment Scale up or down monthly
Coverage gaps Vacation, illness, turnover Team backup available
Best fit

Who uses fractional

Startups

Need senior QA/RA expertise for 510(k) or CE Mark but can't justify a full-time hire yet.

Growing companies

Have a small QA team that needs senior-level backup and guidance.

Companies in transition

Between QA hires, preparing for an audit, or ramping up for a new product.

FAQ

Questions

Is there a minimum commitment?
3-month minimum to allow time for onboarding and meaningful impact. After that, month-to-month with 30 days notice.
Do I get the same person each month?
Yes. You're assigned a dedicated consultant who learns your business. Backup coverage is available if needed.
What if I need more hours one month?
Additional hours available at $175/hour. Or upgrade your plan if needs have permanently increased.
Can they attend our management review meetings?
Absolutely. Many clients have their fractional consultant attend key meetings, audits, and management reviews.
Explore

Related Services

Gap Assessment

AI-powered compliance gap analysis with remediation plans.

Internal Audits

Structured internal audit programs for continuous compliance.

Audit Preparation

Expert preparation for certification and surveillance audits.

Get senior expertise

Quality and regulatory support without the full-time cost.

Get started