Other Safety Expert Services

Our safety team is also good at providing other related safety services as follows.

  • Pharmacoepidemiology support
  • MedDRA coding, SMQs
  • SAE Narratives writing
  • Customized SAE form, AE tabulations/listings
  • Published literature review
  • CCDS development and evaluating labeling and educational materials
  • PV SOPs, templates development
  • Preparation for PV audit and inspection
  • Safety data exchange agreement (SDEA) development
  • PV medical safety assessment trainings
  • Medical safety regulatory consulting services
  • Strategic planning throughout the new drug application registration process
  • Medical and safety expert consultation for regulatory filing communication
  • Strategic planning in the development and growth of your safety departments
  • Providing risk-benefit assessments