Regulatory Support

Every stage of the manufacturing process has regulatory implications. Initially, Cytovance® advises on pre-IND meetings and meeting packages. Production processes and manufacturing strategies are specifically designed for optimal regulatory outcomes. Finally, Cytovance is a critical partner for CMC section preparation, assisting clients throughout the production process to target regulatory success.  Cytovance Biologics is poised to successfully complete regulatory inspections such as a PAI and general CGMP audits.  We host numerous customer quality audits each year in addition to our internal auditing program.