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© 2019 by Graematter

Regulatory Surveillance

WHAT you need to know

WHEN you need to know

Every day...

Be proactive.  Be thorough.  Save time.

Interested in a particular area?

Click the links in the header.

Monitor regulatory performance for your review groups

Keep up with what is happening without spending hours to do it

We do the work for you.

Subscribe today!

 

WHAT WE DO

  

We do the work so you don't have to

 

Odds are, you're here because you are looking for a better way to keep up with regulatory changes.  As regulatory professionals ourselves, we understand.  

 

Graematter has created a simple, efficient way for you to see what's happening every day.  

 

No need to spend your time scanning through dozens of emails.  

No need for you to analyze and re-analyze FDA data to understand the current regulatory performance levels.  

We do the work for you.  Presented in easy to understand graphics and searchable tabular formats.  Filter past the deluge of updates from multiple sources to see what is important to you.

Take back control of your day.  Just login to our One-Click RI dashboards.   

 

Sign up for a free trial today. 

DAILY REGULATORY EVENTS 

See key indices of FDA Performance Data across all product types or compliance measures.  See trends over time.

  • Medical Devices

    • Review times - PMA, 510(k), De Novo

    • Analysis for subgroups - clinical data, combination products

    • Product codes - new and withdrawn

  • Pharmaceuticals​ (in development)​​

REGULATORY PERFORMANCE MEASURES

Keep up to date with regulatory events..

  • One place to check for Daily Regulatory Events

  • New & withdrawn guidance documents

  • Product Approvals

  • Consensus Standards

Want even further detail?  Give us your specifications and get a Custom Report.

CUSTOM REPORTS

Looking even deeper for connections between many types of information?  Our proprietary database integrates many different information sources, sees the connections, and provides keen insights into the interactions and interdependencies that drive regulatory actions.

  • Identify predicate devices

  • Identify patterns in inspection data and citations

  • Inform development with key information for risk assessment

  • Assess the development activity and potential competitors in a specific clinical market area

  • Monitor competitor activity

Have a special research request?  Ask us about getting a Custom Report.

 
 
 
WHAT YOU GET
  • Regulatory events posted daily

  • Product approvals & clearances

  • Guidance documents 

  • Consensus Standards

  • Key indices for regulatory performance

  • Includes submissions, review times & compliance measures

  • Current quarter-by-quarter measures

  • Struggling to find the right predicate?

  • Looking for more specific details about a company or product?

  • You define the regulatory indices for assessing regulatory performance

  • Customized research and reports to your specifications

  • Ask about a custom website built with your regulatory intelligence specifications.

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REGULATORY EVENTS DAILY

 2

REGULATORY PERFORMANCE

 3

CUSTOM REPORTS

Easy to understand analytics

Quickly find what is relevant to your company and products

Monitor competitors' regulatory activity

Sign up for a free trial!

Contact us!

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