Assure Patient Safety with One Team for all Your Safety/PV Documents

Achieve safety-related document compliance with one team that delivers project management, data analysis, medical writing, and medical review capabilities round-the-clock. 

Anticipating Challenges Helps Assure Patient Safety & Report Compliance

  • Proactive management of project timelines
  • Deep regulatory knowledge enables streamlined, yet thorough compliance to regulation and guidelines
  • Flexibility to meet changing requirements and tight timelines

We support safety-related document authoring throughout the 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. 

Contact our Safety and Pharmacovigilance team today.

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Synchrogenix's Proven Record of SuccessSynchrogenix safety and pharmacovigilance proof points