An entirely new therapeutic area has emerged because of COVID-19, and Amarex is proud to help in the fight against the pandemic by offering accelerated COVID-19 clinical product development services. Since the outset of this global public health crisis, our staff have worked passionately and tirelessly to get diagnostics, devices, drugs and vaccines to patients fast.

We are experts at streamlining regulatory and clinical trial testing services, and we continue to apply additional resources to rush timelines for all COVID-19 projects.

Our Experience:

• 20+ clinical projects
• Product types: Four devices/diagnostics, five drug therapies (NCEs, botanicals, biologics, cell therapies and gene therapies), three biologic therapies and two vaccines
• Clinical trials: Three (Phase I and Phase II), two sites, 270+ patients; proof of concept through FDA marketing approval
• Regulatory services: Multiple approved compassionate use, emergency use, EUA, clinical trial agreement, pre-IND meeting, eIND, fast track designation and expanded access applications
• Projects in the U.S., UK, Canada, Europe, Asia and South America
• Full-scope and targeted-scope projects
• Amarex client COVID-19 market approvals: One 510(k)