Integrated Summaries for NDAs

Integrated summaries for NDAs

The Integrated summary that we prepare for NDAs will cover Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) for regulatory submission. Clinical safety professionals provide ISS and ISE services for the pharmaceutical, medical and life sciences industries.

Our Expertise

  • Assessment of Summaries and Analysis of Safety Reports for ISS
  • Evaluation of Adverse Event Effects in Various Subgroups for ISS
  • Assurance of the Appropriate Dosage of the Drugs for ISS
  • Assessment of Collective Summaries and Analysis of Efficacy Reports for ISE
  • Evaluation of Product for Evidence of Therapeutically Active Metabolite for ISE
  • Impact of Concomitant Medications Safety and Efficacy For ISE