A senior FDA expert,
on call 24/7.
Regulatory Advisory pairs the Complizen platform with senior FDA expert hours every month — ongoing, AI-accelerated guidance at every stage, from early design and material choices through testing, submission, and beyond.
- Platform + expert hours, bundled
- Fixed monthly rate
- Annual or month-to-month
The same senior support. A very different bill.
What roughly 15 hours of senior regulatory help costs each month — and what you actually get for it.
A senior regulatory hire, fully loaded — a fixed cost whether you use the hours or not. And no platform.
Roughly 15 hours at $300/hr — billed per call, with no platform and no continuity between engagements.
The Complizen AI platform + 15 senior FDA expert hours, on call every month.
Illustrative monthly cost for ~15 hours of senior regulatory support. Figures are typical market ranges, not quotes.
A standing retainer, run inside one workspace.
Pick your monthly tier
Each tier bundles a Complizen platform workspace with a set number of senior FDA expert hours every month. Pick the level of support your team needs.
Experts work alongside you
Your senior FDA experts work directly inside the Complizen workspace — same projects, same documents, same context as your team. No handoffs, no black box.
Spend hours how you need
Strategy, design controls, QMS, testing, submissions, training — direct your monthly hours at whatever is in front of you. The mix is yours to set, month to month.
Scale up when it matters
Need more in a busy month? Additional hours are available on demand at fixed, published rates — with a standing discount on the Advanced and Dedicated tiers.
Every stage of development — not just submission day.
This is general regulatory consulting, not a one-time project. Engage your expert early — at concept, material selection, and design — and again at testing, submission, and post-market. The point is to be in the room before the costly decisions, not after.
What a single wrong material choice can add in downstream testing. A 30-minute conversation early can save it — and that’s exactly what the retainer is for.
Regulatory strategy & FDA submissions
Pathway decisions, predicate strategy, Q-Subs, and hands-on work on 510(k), De Novo, and PMA submissions.
Quality Management Systems & compliance
QMS build-out and upkeep, SOPs, internal audits, and readiness for inspections under 21 CFR 820 and ISO 13485.
Product engineering & design controls
Design history files, design control workflows, and the documentation that keeps engineering and regulatory in step.
Risk management & validation testing
ISO 14971 risk files, test plan design, protocol review, and validation strategy across bench, software, and clinical.
Operations & vendor management
Supplier qualification, vendor oversight, and the operational scaffolding that keeps a regulated product moving.
Compliance & quality system training
Practical, role-specific training for your team — so regulatory and quality practices stick after the call ends.
More hours, deeper support, each step up.
Every tier bundles a Complizen workspace with senior FDA expert hours each month. Commit annually for the best rate, or stay month-to-month with no long-term commitment.
Essential
Steady senior support for a focused team.
hours / month
- Starter workspace included
- 3 active projects · 1 seat
- Generous monthly AI usage
- Overflow hours at standard rates
Advanced
Ongoing partnership for teams in motion.
hours / month
- Everything in Essential, plus:
- Pro workspace — unlimited projects
- 3 seats · unlimited AI usage
- Nearly 4× the monthly expert hours
- 10% off all overflow hours
Dedicated
A senior FDA team embedded in your work.
hours / month
- Everything in Advanced, plus:
- Over 2.5× the monthly expert hours
- Your deepest standing bench of senior time
- 15% off all overflow hours
Run past your included hours in a heavy month? Additional on-demand hours are available at fixed, transparent rates — no renegotiation, no surprise invoices.
Built for teams that want a regulatory expert on tap — at every stage.
Teams in active development
A senior expert in the room for design, material, and testing decisions — when the right call saves the expensive fix, not after it's already baked in.
Companies not ready to hire
You need ongoing QMS and compliance help, but a full-time RA hire is premature. Get senior coverage without the fixed headcount.
International manufacturers
Entering the US and want a persistent regulatory presence on the ground? Keep a US-focused FDA team engaged month after month.
“Complizen turned what felt like a four-month scramble into a focused sprint. The expert review gave our team confidence we couldn’t have built submitting alone.”
Tell us where you are. We’ll point you the right way.
A 30-minute call with a member of our team. We’ll get a feel for where you are and point you in the right direction — no prep, no pressure.
