“Columbia, MD, July 30, 2018 –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.”
Source: CORMAC, July 27, 2018.
G2X TAKE: While not huge in terms of overall contact value at just under $1M, this is a big pickup for woman-owned and 8(a) small business CORMAC, as it builds on their long standing relationship with FDA leading and supporting a number of database initiatives, to include providing support for the CDER Access Database.
