Cortellis Regulatory Intelligence

Your single source to navigate the regulatory landscape and efficiently drive strategic decisions

Maintain compliance, increase approval rates, and expand to new markets using a single source of regulatory information that reduces the workload of remaining up-to-date and is complemented by in-depth knowledge and analysis.

Staying current with the ever-changing regulatory landscape is challenging, often introducing uncertainty around maintaining compliance. Cortellis Regulatory Intelligence is a timely and comprehensive regulatory database that spans all regulatory functions across the R&D lifecycle, providing access to:

  • Daily updates to regulatory source documents, such as FDA483s, approval documents, inspection reports, and submission forms.
  • Detailed summaries in English of local regulatory practices and reference documents, translated by regulatory professionals who are also native language speakers.
  • Proprietary regulatory intelligence reports, manually curated by our editorial team.
  • Full coverage of FDA AdComm meetings since 2001 and FDA workshops since 2003

 

Through the in-depth analysis of our regulatory experts, who unravel the complexities of regulatory pathways, Cortellis Regulatory Intelligence acts as a single reliable source to:

  • Monitor regulatory changes.
  • Understand submission routes and local practices.
  • Efficiently compare regulatory requirements across countries.
  • Maintain compliance with GXP and drug safety reporting requirements.?
  • Conduct pre- and post-marketing surveillance.

>200,000

Regulatory Documents for Drugs, Biologics, Medical Devices and IVDs

80

Modules for country- and region-specific regulations

>1,600

Exclusive English translations for crucial regulatory documents

>7,000

Regulatory intelligence reports

>10,000

Inspection documents

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