Cognition for Biopharma Regulatory and Quality Leaders
Secure approval with a proven framework for audit readiness and regulatory precision.
Compass® BIO: Greater Traceability, Greater Confidence
The regulatory compliance landscape for Biopharma products is always changing, but one thing is constant: the need for clear, traceable data that is standardized and appropriately structured for your regulatory success.
Compass BIO gives regulatory and quality leaders the support they need to confidently prepare for submission, audits, and every regulatory hurdle that comes their way.
Be Submission-Ready
Traceability, Always
Ace Your Audits
Schedule Your Compass BIO Demo
Key Features for Regulatory and Quality Leaders
Transition from manual data consolidation to automated precision. Compass BIO gets your team Module 3-ready with standardized, structured data
Compass BIO’s change once, update everywhere functionality ensures critical changes are reflected across your entire dossier
Generate and export submission-ready documentation at the click of a button, streamlining the path to market
As a single unified system, Compass BIO collects and standardizes massive amounts of data that give critical context for global regulatory compliance
Face submissions and inspections with confidence thanks to Compass BIO’s comprehensive documentation and automated audit trails
What Regulatory Leaders Are Saying
“Cognition Corporation’s Compass BIO is our electronic reporting environment supporting
automated transcription and aggregation of large analytical data sets from data sources to tabular reports to submissions.”
Senior Scientific Director
Strategic Science and Innovation
Biopharma Success Stories
Explore how Compass BIO bakes regulatory readiness into every step of the Biopharma product lifecycle.
Cognition:A Trusted Partner for Biopharma
Whether they’re bringing their first drug product to market or their hundredth, Cognition helps Biopharma pioneers proceed with regulatory confidence and peace of mind about their data integrity. Compass BIO is purpose-built to bypass the challenges that hinder the drug development lifecycle, building traceability, data lineage, and knowledge management into every step from TPP through Tech Transfer.
Make Regulatory Compliance Your SOP
See our out-of-the-box CMC e-reporting solution for yourself. Book your demo of Compass BIO.