CMC Superhero Services

Our CMC Superhero Services supporting Analytical and Formulation Development projects for Drug Research are highly flexible and tailored to fit the needs of your overall drug development strategy and available resources. Whether under a fixed price, hourly, or FTE arrangement we can either work in our lab facility or at your facility to get the assignment completed rapidly. Services include Pre-approval Inspection Audits (PAI) and readiness planning, Consent Decree resolution, Quality Systems analysis/optimization as well as notebook data review and close out's of deviation reports.