When Your Regulatory Team Needs More Hands
"We have a legacy DHF with hundreds of documents."
DHF Remediation"Our CER team has too much literature to review."
Clinical Evidence & Literature Support"The Notified Body has given us 40 deficiencies."
Deficiency Response Support"Our regulatory team is overloaded with PMS."
PMS & PMCF Support"We have requirements but traceability is weak."
Traceability & Documentation Review"We need additional regulatory resources for 6 months."
Dedicated Regulatory FTEOur Medical Device Regulatory Services
Technical Documentation & DHF Support
- DHF review & gap assessment
- DHF remediation
- Technical documentation review
- GSPR traceability
- Design traceability
- Deficiency response support
Clinical Evidence & CER Support
- Literature search & screening
- Evidence extraction & appraisal
- CER support
- Evidence gap analysis
- Reference management
- QC
PMS, PMCF & Vigilance Support
- PMS literature surveillance
- PMCF literature support
- PSUR support
- Complaint & vigilance review
- Signal detection support
- Reporting support
Risk, Traceability & Design Controls
- Risk documentation review
- Risk-to-design traceability
- Requirements traceability
- Change impact assessment
- Gap identification
- QC
Software, AI & Cybersecurity Documentation Support
- Software documentation review
- Software traceability
- Cybersecurity documentation
- AI / SaMD support
- Version consistency
- QC
Regulatory Operations & Intelligence
- Regulatory intelligence monitoring
- Change impact assessment
- Regulatory documentation QC
- EUDAMED support
- Backlog support
- Ongoing maintenance
How We Work
Project-Based
Defined scope & deliverables
- Defined scope & deliverables
- Fixed timeline
- Best for specific projects
Dedicated Resources (FTE)
Ongoing support
- Ongoing support
- Extension of your team
- Ideal for recurring work
Hybrid
Flexible collaboration
- You decide the strategy
- We handle execution & QC
- Best for complex programs
Quality Built Into Every Work Package
Analyst
Research / Documentation / Evidence
Regulatory Specialist
Work Package Review
Senior Reviewer / QA
Technical Review & QC
Client
Final Approval
White-Label Support for Regulatory Consultants
Let's work together
Execution-first
We perform the work, not just recommend it.
Scalable
Add capacity when your workload increases.
Flexible
Project, dedicated resource or hybrid.
Quality-controlled
Structured multi-level review.
Confidential
Operate behind your team when required.
Global regulatory support
Across US, EU and other major markets.
Representative Project Experience
Real-world examples of how we help
Legacy DHF Remediation
Bringing a legacy DHF up to current expectations.
CER Literature Support
Reducing the literature review burden for a clinical evidence team.
Deficiency Response Support
Turning regulatory comments into an executable plan.
Regulatory Consultant Capacity
Helping a consultancy scale without hiring.
Global Regulatory Reach & Industries
Global Regulatory Support
End-to-end technical documentation and lifecycle regulatory operations aligned with international authorities and Notified Bodies.
Confidential Delivery Model
We work under your direct leadership as a silent, brand-neutral delivery pod. Scale your delivery throughput without compromising client relationships.
Industries & Device Types
We support documentation and regulatory operations across diverse device classifications: