Regulatory Knowledge Support (RKS)

About RKS

RKS consultants will help you understand how to get your therapeutic product from the bench to the bedside.

Our Expertise

RKS can advise on the necessary steps for Investigational New Drug (IND)-enabling studies, including molecular biology; process and product development; analytical, biophysical, and functional assay development; formulation development; non-clinical studies; and quality control and assurance. RKS can also support the design of IND applications, including preclinical modules and Chemistry, Manufacturing, and Controls plans. When combined with research ethics consultation service, RKS can help design clinical modules.

RKS is modeled after biotechnology organizations to develop and transfer biopharmaceutical products from development to pilot or industrial manufacturing organizations and to collaborate with partners for the preclinical and clinical development of these products.

Areas of Support

• Support for drafting protocols, standard operating procedures, technical reports, and other regulatory-enabling documents

• Proactive review of the translation process to ensure study addresses the requirements of regulatory bodies

• Guidance on how to build a quality management system needed to reach clinical activities

• Guidance on how to design research projects to maximize reproducibility and conduct rigorous and transparent research

• Assistance with IRB submissions at BCM, VA and UH.