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, and processes are scaled up to meet the needs for clinical trials. As process knowledge rapidly evolves through Process Development and first-hand experience, so does the understanding of risk and practical versus theoretical. Managing risk while maintaining timelines requires careful planning, execution, monitoring and excellent communication. Project by highly experienced, interdisciplinary teams to ensure all aspects of synthesis, engineering and analytical are considered and controlled using phase-appropriate approaches.

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.

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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