BIOPHARMA INTELLIGENCE | DISCOVERY, CLINICAL & REGULATORY

Cortellis Regulatory & HTA Intelligence

Navigate the regulatory landscape and efficiently drive strategic decisions

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Ensure regulatory and HTA success while maintaining compliance

Develop agile regulatory and market access strategies while maintaining compliance with global regulatory requirements.

Confidently comply with regulatory guidelines, negotiate pricing and reimbursement, and increase successful submission outcomes in markets worldwide with comprehensive, expertly analyzed regulatory and market access information.

How we help

  1. Understand regional differences and get treatments to patients faster
    Quickly compare and monitor regulations and understand regional HTA outcomes across markets with detailed summaries of local practices and reference documents.
  2. Maintain regulatory compliance across development lifecycle 
    Maintain compliance, increase approval rates and quickly expand to new markets by unraveling the complexities of regulatory pathways through a single, reliable source.
  3. Confidently prepare HTA submissions and evidence dossiers
    Gain deep insights into the attributes required for achieving a positive HTA outcome across multiple geographies by assessing combined regulatory, health technology assessment (HTA) and clinical trial data.

Why choose us

Comprehensive repository of regulatory intelligence

Cortellis Regulatory Intelligence provides:

  • full global coverage, including drug and biologic regulatory information, medical devices and IVDs
  • comprehensive coverage of FDA AdComm meetings and workshops
  • 215K+ regulatory documents
  • 185K+ agency documents

Detailed summaries, reports and tables

Cortellis Regulatory Intelligence gives you access to:

  • 3K+ regulatory summaries for each stage of the drug development lifecycle
  • 8K+ analyst-written intelligence reports
  • global regulatory comparison tables with links to original source documents, including FDA 483 forms, approvals, inspection reports and submissions

Signature linkage of regulatory, HTA and clinical trial data

Context Matters integrates:

  • 2M+ data points integrated across regulatory, reimbursement and clinical trials
  • 16 HTA data markets
  • 4 global regulatory agencies
  • 50+ diseases across eight therapeutic areas
  • 8K+ HTAs
  • 6K+ regulatory labels

Highly indexed with faceted search and built-in analytics

Context Matters provides:

  • ability to search and compare across agencies, disease, drug, and company snapshots on standardized assessment variables
  • ability to compute and visualize aggregations, groupings, and measure that are easy-to-build
  • built-in sharing tools, custom views and tailored alerts

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Want to learn more?

Contact us to schedule a demo of Cortellis Regulatory Intelligence.

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