Clinical Trial Material

During the clinical stage of development, API requirements for quality and scale are rapidly evolving. All the while, new risks are introduced as processes are scaled up to meet supply demands for clinical trials. As process knowledge rapidly evolves and first-hand manufacturing experience is achieved, sponsor and CDMO better understand risk as practical or theoretical. Managing risk while maintaining timelines requires careful planning, execution, monitoring and excellent communication. Project management needs to be highly experienced to lead interdisciplinary teams and ensure all aspects of synthesis, engineering and analytical are considered and controlled using phase-appropriate approaches.

Clinical trial team at work in lab

At Regis, scaling up complex chemistries is in our DNA. Upon receiving a project for GMP synthesis, Regis will assign a Project Team comprised of highly skilled people with experience and training in Process Chemistry, Analytical Development, Solid State Chemistry, Scale up, Project Management and Quality Assurance. Our project teams will work with you to develop a plan and prioritize the development efforts to deliver API on-time, using cost effective methods, and of suitable quality for use in your study.

Clinical trial team at work in lab

At Regis, scaling up complex chemistries is in our DNA. Upon receiving a project for GMP synthesis, Regis will assign a Project Team comprised of highly skilled people with experience and training in Process Chemistry, Analytical Development, Solid State Chemistry, Scale up, Project Management and Quality Assurance. Our project teams will work with you to develop a plan and prioritize the development efforts to deliver API on-time, using cost effective methods, and of suitable quality for use in your study.

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