Opportunity Assessment

A government funded research institute required a technical audit/risk assessment of the manufacturing facility identified for GMP production as well as preparation of a pre-CTA meeting package compliant with Health Canada regulations for a virus project.

C2C completed a site audit, gap analysis and risk assessment and prepared recommendations and action plan for the facility.

C2C prepared a pre-CTA package and met with Health Canada to review a proposed clinical and regulatory strategy for first-time-in-man studies.