Due Diligence

Challenge

Our client wanted consultation and technical support for site selection and due diligence of an organization’s API manufacture and optimization and auditing services.

Solution

C2C was selected to provide consultation and technical support for site selection and due diligence of an organization’s API manufacture and optimization as well as quality and technical support for formulation and delivery methodology for an intranasal/sublingual dosage form. Auditing services required meeting regulatory requirements (US and Canada) along with appropriate risk assessment and remediation planning to ensure readiness for Phase I/II clinical studies.