HHS/FDA awarded a 4-year sole source contract to CORMAC to provide technical, database and analytical services for Compliance Program Information System (COMPLIS). CORMAC will provide support for the Office of Scientific Investigation (OSI) and the Office of Study Integrity and Surveillance (OSIS) in the Center for Drug Evaluation and Research (CDER). The contract includes tracking of pending assignments, untitled letters, complaints, inspectional outcome packages, enforcement actions, inspectional deficiencies, audit dates, good laboratory practice (GLP) and Bioequivalence (BE) data, and human subjects protection consults. It also provides quantitative data (inspections metrics) on inspections overseen by OSI & OSIS for all OSI and OSIS divisions, branches, and programs.
CORMAC is honored to be selected by FDA/CDER to continue to provide support to these tools that are essential to protecting public health.News