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Transforming Regulatory Intelligence

Transforming Regulatory IntelligenceTransforming Regulatory IntelligenceTransforming Regulatory Intelligence

 FDA Intelligence Reimagined: Turning Regulatory Complexity into Strategic Advantage 

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Regulatory Intelligence Services

Innovative Technology

Graematter leverages SOFIE, a multi-dimensional intelligence platform that uses advanced artificial intelligence tools to transform regulatory data into strategic business insights.  

  

Key features of our SOFIE Regulatory Intelligence System:

Comprehensive view across multiple regulatory information sources

Transforms complex data into strategic insights 

Investing in a Startup

Mergers & Acquisition Due Diligence

Portfolio Diversification Strategy

Challenge: Assess the viability of an innovative medical device startup

•  Comprehensive regulatory pathway analysis •  Competitive technology positioning                   •  Compliance risk assessment 

•  Market entry probability evaluation  

Portfolio Diversification Strategy

Mergers & Acquisition Due Diligence

Portfolio Diversification Strategy

Challenge: Identify emerging MedTech investment opportunities

•  Regulatory landscape mapping 

•  Emerging technology trend tracking 

•  Competitive intelligence analysis 

•  Innovation potential assessment  

Mergers & Acquisition Due Diligence

Mergers & Acquisition Due Diligence

Mergers & Acquisition Due Diligence

Challenge: Evaluate a potential medical technology acquisition

•  Competitive landscape positioning 

•  Adverse event safety profile assessment 

•  Comparative device compliance analysis  

•  Regulatory history reconstruction 

Breakthrough MedTech Concept

Competitive Technology Positioning

Mergers & Acquisition Due Diligence

Challenge: Assess regulatory feasibility of novel medical device technology

•  Similar device/technology history 

•  Comprehensive regulatory path mapping 

•  Competitive technology landscape analysis 

•  Identify potential compliance challenges  

Regulatory Submission Strategy

Competitive Technology Positioning

Competitive Technology Positioning

Challenge: Develop optimal FDA submission strategy for a complex medical device

•  Optimal device approval pathways 

•  Detailed historical submission analysis 

•  Identify reviewer interaction patterns 

•  Potential compliance risk assessment  

Competitive Technology Positioning

Competitive Technology Positioning

Competitive Technology Positioning

Challenge: Understand competitive landscape and differentiation potential

•  Regulatory success rate comparison 

•  Market positioning insights 

•  Detailed competitive device mapping 

•  Technological similarity analysis  

What our customers say about us

Venture Capital Executive

Venture Capital Executive

Venture Capital Executive

  “A strategy-enabling technology that provides unprecedented historical data to be applied to all levels of opportunity, development, business assessment, and financial modeling.”  

Technology CEO

Venture Capital Executive

Venture Capital Executive

 “I am stunned by the amount of intelligence Graematter can extract from the regulatory data.”  

Venture Capital Executive

Venture Capital Executive

Venture Capital Executive

 "We [investors] may know review times. You can answer how complex the project, how much money to prepare, who are your competitors, and how innovative they are.”  

Venture Fund Manager

Venture Fund Manager

Venture Capital Executive

 “Graematter Software is a Portfolio Strategy Tool.” 

Medical Device CEO

Venture Fund Manager

Medical Device CEO

"Taking regulatory intelligence to a higher level."

Medical Device CEO

Venture Fund Manager

Medical Device CEO

 “Providing insights never before available for medical devices.” 

Let Graematter be your Regulatory Intelligence partner

  Graematter is a specialized regulatory intelligence firm that provides expert analysis and interpretation of complex medical device and healthcare regulatory landscapes. 

We power SOFIE, our advanced intelligence platform, with deep domain expertise that transforms raw data into strategic insights.

What we do

What we can do for you

For INVESTORSFor Medical Device InnovatorsFor Corporate Business DevelopmentFor Regulatory Professionals

Contact Us

We would like to hear from you!

Graematter, Inc

St. Louis, MO, USA

info@graematter.com +1 636-405-7498

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US Patent 7,734,606

US Patent 9,292,623

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