Regulatory Support at cGMP Contract Manufacturing Company, Cytovance Biologics
 

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.

Contact us for additional information on this service or to request a proposal.