Company Tagline
Regulatory & clinical strategy consulting for small companies navigating US FDA requirements for health software.
Industry Category
Business Keywords
Company Description
EvidenceX, LLC is a premier business consulting and services firm specializing in regulatory and clinical assessment strategies. With a focus on AI-enabled healthcare software products, including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and Clinical Decision Support (CDS) systems, EvidenceX, LLC helps startups and small companies successfully navigate the complex US FDA regulatory landscape.
EvidenceX, LLC offers expert guidance in various areas, including regulatory strategy assessment and gap analysis, product development aligned with FDA regulations, early-stage regulatory planning, clinical study design and execution, and post-market updates. The company also provides support for technical documentation for regulatory submissions and FDA deficiency resolution and communication.
EvidenceX, LLC is dedicated to helping clients accelerate market entry, reduce risk, and maximize long-term success. Our commitment to excellence ensures that innovative healthcare products are brought to market with confidence. We invite the manager of EvidenceX, LLC to create a customized and exclusive company showcase and product listing on our platform to further enhance your market presence.
Key Personnel / Employees
Compare Companies Side by Side
Compare EvidenceX, LLC with 3 companies in Business-Consulting-and-Services
| Comparison Field |
EvidenceX, LLCMain Company |
Pharma Engineering S...View Profile |
CC
CCS Associates, Inc.View Profile |
Neighborhood: The He...View Profile |
|---|---|---|---|---|
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Founded Year
|
— | 2015 | 1985 | 2018 |
|
Company Size
|
— | 2-10 | 51-200 | 51-200 |
|
City
|
Golden, CO | San Jose, CA | Boulogne-Billancourt, Île-de-France | |
|
Country
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United States | United States | ||
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Skills & Keywords
Comparing with main company
|
16 Total Skills
Regulatory Strategy
Clinical Assessment
FDA Regulations
Healthcare Software
Medical Device
AI in Healthcare
Business Consulting
Clinical Assessment Strategy
FDA Communication
Gap Analysis
Performance Assessment Strategy
AI-enabled Medical Device
Health Software
Product Development
Regulatory Writing
Technical Writing
|
8 Total
8 Unique
Unique Skills:
Capital Projects Management
CMC Development
Cross-functional Team Management
Design Control
NDA Authoring
Person-in-Plant
+2
|
30 Total
30 Unique
Unique Skills:
Cardiovascular
Central IRB Management
Clincial Study Report Preparation & Review
Clinical Development
Clinical Study Start-up & Activation
Clinical Trial Management & Monitoring
+24
|
4 Total
4 Unique
Unique Skills:
Biotech
Derisking
Market Access
Medtech
|
4
Total Companies1985
Oldest Founded1
Countries57
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Alternative Company Names
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