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