Services & Pricing
Clear Strategy. Real Experience. No Guesswork.
Most regulatory consultants learned FDA from a textbook. We learned it by doing it — building a BSL-2 lab from scratch, navigating a strategic 510(k) withdrawal and resubmission, and achieving FDA clearance in just over three months.
That’s not a credential. That’s a track record.
How We Work With You
Not sure which pathway applies to your device? Stuck on predicate selection? Need a second opinion before you submit — or before you spend $50,000 on the wrong approach? This is a focused, founder-to-founder working session. You bring your device, your questions, and your current thinking. We bring clarity.
What’s Included:
- 90-minute video call with a senior regulatory strategist
- Pre-call intake questionnaire so we hit the ground running
- Written summary of key recommendations delivered within 48 hours
- 30-minute follow-up call within 30 days
A comprehensive written report mapping your device’s complete regulatory pathway — from classification through clearance. This is the foundation every 510(k) submission should be built on, and most founders skip it entirely.
What’s Included:
- Device classification analysis (21 CFR identification)
- Predicate device landscape review (3–5 strong predicate candidates with rationale)
- Recommended 510(k) pathway with risk assessment
- Pre-Submission strategy recommendations
- Testing and biocompatibility requirements overview (ISO 10993)
- Summary of likely FDA questions based on device type
Embedded regulatory expertise without the full-time overhead. We become your de facto regulatory affairs team — available when you need us, scaling with your milestones.
What’s Included:
- Up to 10 hours/month of direct advisory support
- 510(k) strategy, Pre-Sub preparation, and FDA communication support
- Review of regulatory documents, test protocols, and submissions
- Biocompatibility and testing guidance (ISO 10993)
- Monthly check-in call to track milestones and adjust strategy
- Priority email response within 24 business hours
Optional Add-Ons:
- Additional hours: $175/hour
- Regulatory Project Management (full submission coordination): Custom quote
- FDA Deficiency Response Support: Custom quote
Frequently Asked Questions
Do you work with all device types?
We specialize in Class I and Class II medical devices pursuing 510(k) clearance. If your device is Class III or requires a PMA, we can still help you understand your pathway and refer you to the right resources.
Are you a regulatory consulting firm or a solo practice?
Evolve Regulatory Strategies is a boutique practice. You work directly with senior-level expertise — not a junior associate handed off after the sales call.
What if I need more than 10 hours in a month?
Additional hours are available at $175/hour. We’ll always give you a heads-up before you exceed your monthly allocation.
Can you help after clearance — with labeling, post-market, or product changes?
Yes. Post-clearance regulatory support including labeling review and 510(k) amendments for device changes are available. Contact us to discuss your specific needs.
Do you sign NDAs?
Absolutely. We sign mutual NDAs before any substantive discussion of your device or technology.