Rely on one expert team for all your needs

Anticipating challenges helps assure patient safety and report compliance.  You can confidently achieve safety-related document compliance with one expert team that delivers project management, data analysis, medical writing, and medical review capabilities around-the-clock

We support safety-related document authoring throughout the entire drug development lifecycle for all major global agencies. This includes safety narratives, eCTD documents (2.7.4, ISS), aggregate reports, risk management plans, cumulative safety analysis, literature searches, global value dossiers, and signal evaluations.

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Expect and understand your risks early

We combine our deep expertise with responsive, customer-centric processes to be compliant and ensure patient safety.

  • Deep regulatory knowledge enabling streamlined, yet thorough compliance to regulations and guidelines
  • Flexibility to meet changing requirements and tight timelines
  • Proactive management of project timelines
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Proven record of success with safety-related documents

We expertly author all safety-related documents required throughout the drug development lifecycle, including safety narratives, eCTD documents (2.7.4, ISS), aggregate reports, risk management plans, cumulative safety analysis, literature searches, global value dossiers, and signal evaluations.

  • DSUR/IND Annual Report
  • RMP
  • PSUR/PBRER/PADER
  • Addendum to Clinical Overview
  • Signal assessment report
  • Safety analysis document/report
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