As a 503B Outsourcing facility that is registered and inspected by the FDA, Edge has the ability to produce GMP material for clinical drug trials. With several drug trials currently underway and decades of expertise in both R&D and clinical pharmacy on staff, Edge is an ideal partner for sourcing GMP quality doses for early drug trial phases.
Edge provides the following benefits to both small and large manufacturers undergoing clinical trials:
Edge offers a cost effective solution for obtaining GMP quality material when a contract manufacturer is not an ideal partner.
Edge can accommodate a wide range of batch sizes depending on the requirements of the study including patient-specific dosing. Automated and semi-automated processes for filling containers are available for higher volume production.
Edge's rapid development process and streamlined production facility mean faster turnaround compared with traditional suppliers.
Even before undertaking a new project, customers are able to meet key team members within chemistry, microbiology, quality, pharmacy, and production. It is as important to us as it is to you that we are the right fit for your project.
Edge prides itself on being as transparent as possible with our customers. As a drug trial client you will have full and constant access to department heads across the entire company and throughout the entire process from contracting and R&D until receipt of finished doses.
Call or email us to discuss your drug trial, or use the form below to register for an account and a member of our team will reach out to you.