Squarepoint-Pointcarre

• Welcome
• Our company
• Our services
  • Biostatistics
  • Datamanagement
  • Medical writing
    • Clinical development
    • Regulatory affairs
    • Publications and presentations
  • Pharmacokinetic analysis
  • Project management
• Our works
• Our partners
• Our customers
• Contact us
  • Map
• Last news

Regulatory affairs

Exhaustive literature exploration

Nonclinical and clinical summaries and tabulated summaries (CTD Module 2)

Nonclinical Overviews (CTD Module 2.4)

Clinical Overviews (CTD Module 2.5)

Patient information leaflet (PIL)

Summary of Product Characteristics (SPC)

Test of readability and usefulness of patient information leaflet (PIL)

Contact and advice from key opinion leaders from the preclinical and clinical fields