AS Write Sebastian Kristof's medical writing website

Services

  • Investigative New Drug (IND) applications
  • New Drug Applications (NDAs)
  • Clinical study reports (CSRs)
  • Clinical study protocols and protocol amendments
  • Investigator's brochures (IBs)
  • Adverse event (AE) and serious adverse event (SAE) narratives
  • Package inserts
  • Informed consent documents
  • Clinical data management plan
  • Protocol deviation (PD) reports
  • Related clinical and regulatory documents

Pledge to Clients

  • Timely and transparent communication
  • Solid planning and project management
  • The highest standards of research ethics and writing integrity
  • The utmost respect to deadlines