Our Expertise

for Patients

We are experts in Expanded Access / Compassionate Use

  • Direct hands on experience leading pharmaceutical company expanded access programs
  • Over 50 years' drug development and 25 years compassionate use experience
  • Global expertise of local regulatory requirements for expanded access (US) and compassionate use (non-US)
  • Design of Expanded Access programs and Policies
  • eTool customizable for your company
  • Knowledgeable staff ready to administer your Expanded Access program
  • FDA Navigator ready
  • End to End management:  Physician on-line request interface to approval and delivery of investigational agent to physician
  • Working with IRBs and bioethical experts
  • Experience with the Food and Drug Administration and global Health Authorities           
  • Expanded Access for Individual Patients
  • Expanded Access for Groups of Patients (EAP or Cohort Protocols)
  • Early Access System™
  • Post Trial Access