Invest $80K, Save $2M in Delays
Most medtech companies waste $2-5M on regulatory mistakes and timeline overruns. Our transparent pricing lets you budget with confidence—while our proven processes eliminate the costly surprises that bankrupt startups.
Here's the truth: A $150K investment in expert regulatory guidance will save you $2M+ in avoided delays, rejected submissions, and compliance disasters. Our clients reach market 40% faster than industry average—generating revenue while competitors burn cash.
We don't play games with hidden fees or scope creep. Every engagement includes a fixed-price guarantee and milestone-based billing—so you know exactly what you're paying and what you're getting.
Hourly Rates
| Service Type | Associate Level | Manager Level | Partner Level |
|---|---|---|---|
| Regulatory Affairs/Submission | $80/hr | $120/hr | $150/hr |
| Quality System/Compliance | $80/hr | $120/hr | $150/hr |
| Design Engineering | Per Inquiry | Per Inquiry | Per Inquiry |
| Marketing | $70/hr | $100/hr | $130/hr |
| General Business Consulting/BD | — | — | Per Inquiry |
Regulatory Affairs/Submission
Quality System/Compliance
Design Engineering
Marketing
General Business Consulting/BD
Associate Level ($70-80/hr)
- 2-5 years of experience
- Handles routine regulatory tasks
- Works under senior supervision
Manager Level ($100-120/hr)
- 5-10 years of experience
- Leads regulatory projects
- Direct client communication
Partner Level ($130-150/hr)
- 10+ years of experience
- Strategic advisory services
- Complex regulatory challenges
Typical Project Investment Ranges
While every device is unique, these ranges reflect typical budgets for common regulatory milestones. All projects include a fixed-price cap.
FDA 510(k) Submission
$15k - $25k
For Class II devices with moderate complexity.
- ✓ Gap analysis
- ✓ Predicate selection
- ✓ Full dossier preparation
- ✓ eStar submission support
QMS Implementation
$12k - $20k
Full 21 CFR 820 / ISO 13485 setup.
- ✓ Quality Manual
- ✓ 20+ SOPs & Forms
- ✓ Team training
- ✓ Mock audit
China NMPA Entry
$30k - $50k
End-to-end registration & local agent.
- ✓ Local Agent representation
- ✓ Type testing coordination
- ✓ Clinical evaluation
- ✓ Dossier translation
Rapid Red Flag Audit
$5k - $10k
72-Hour turnaround for VC/PE diligence.
- ✓ Regulatory Pathway Verification
- ✓ Clinical Data Integrity Check
- ✓ Reimbursement Code Alignment
- ✓ "Go / No-Go" Recommendation
Predictable Costs. Guaranteed Outcomes.
Most 510(k) projects run $120-180K all-in. CE Mark certifications typically cost $80-150K. We provide fixed-price quotes with performance guarantees—so you can confidently forecast your regulatory budget without nasty surprises.