SMO Services

  • Site feasibility support for Sponsors/CROs
  • Investigator and Site Selection
  • Trial Monitoring
  • Site Management

Regulatory Affairs and Writing

  • Clinical Overview Writing
  • Nonclinical Overview Writing
  • Summary of Product Characteristics (SmPC) Preparation
  • Product Information (PI) Preparation
  • Investigators Brochure (IB) Preparation
  • Product Information Leaflet (PIL) Preparation
  • Consumer Medicine Information (CMI) Preparation
  • Guidance on Dossier Preparation

Pharmacovigilance

  • PSUR Writing





Clinical Research(BA/BE)

  • BA/BE Study Design
  • Clinical Risk Evaluation Sheet Preparation

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