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© 2019 by Graematter

Regulatory

Intelligence

 

WHAT you need to know

WHEN you need to know

Every day

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Regulatory Intelligence Department

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HOW IT WORKS
  • Regulatory events posted daily

  • Safety alerts

  • Product approvals & clearances

  • Meeting notices

  • Guidance documents 

  • Key indices for regulatory performance

  • Includes submissions, review times & compliance measures

  • Current month-by-month measures

  • Annual subscription

  • You define the regulatory indices for assessing regulatory performance

  • Current, up-to-date results

  • Customized research and reports to your specifications

  • Choose the information type needed

 1

REGULATORY EVENTS DAILY

 2

REGULATORY PERFORMANCE

 3

SPECIAL REPORTS
 

WHAT WE DO

REGULATORY EVENTS
DAILY

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

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

  • Product codes

  • Inspection results

  • Recalls

REGULATORY PERFORMANCE MEASURES

Keep up to date with regulatory events..

  • One place to check for Daily Regulatory Events

  • New guidance documents

  • Safety alerts

  • Meeting announcements

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

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