- US FDA Manufacturing establishment registration
- USA FDA agent services
- Device product registration/listing
- US FDA 510(k) submissions
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- US FDA De Novo applications
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- EU CE mark compliance (MDD & MDR)
- China NMPA (cFDA) approval
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The Only Regulatory Team That Guarantees First-Time FDA Approval
Stop gambling with consultants who "try their best." Our 12-expert global team has achieved a 98% first-submission success rate across 300+ FDA, CE Mark, and NMPA applications. Your approval or your money back.
Specialized Expertise by Device Type
We don't just know regulations; we understand your technology.
Software / AI (SaMD)
Deep experience with IEC 62304, cybersecurity guidance, and AI/ML change control plans.
In Vitro Diagnostics
Expertise in CLIA waivers, molecular diagnostics, and POC testing platforms.
Active Implantables
Proven track record with Class III pacemakers, neurostimulators, and pumps.
Orthopedics & Spine
Navigating biomechanical testing, 510(k) predicates, and wear testing requirements.
China Market Entry Without the IP Risk
Entering China is lucrative but risky. Most consultancies outsource to local vendors you've never met, exposing your intellectual property.
Wholly-Owned Subsidiary
We have our own office in Beijing with full-time employees—no third-party outsourcing.
Ironclad Data Protection
Your technical files never leave our secure, encrypted internal servers.
Your Competitors Are Already 6 Months Ahead
Every week you wait is another week they dominate your market. Book a free 30-minute strategy call to see how we can fast-track your approval—before your window closes.