Life science sponsors require that contract manufacturers (CMOs) meet the same quality and safety requirements that the FDA requires of them. Further, the FDA wants outsourced manufacturing to be better integrated into the operations of the sponsor organization. One component of effective collaboration between sponsors and their CMO partners is a common data platform to mitigate risks.

Aegis Analytical’s Discoverant CM is a Contract Manufacturing Process Intelligence software platform that provides a collaborative data access, contextualization, analysis and reporting environment that eliminates geopgraphy as a factor in the working relationships among CMOs and their sponsors.

Leading biotech and pharmaceutical companies and CMOs share data and results through Discoverant CM across disparate manufacturing sites to:

  • Provide raw data, KPIs and/or analytical reports to multiple sponsors or CMOs by site, product and/or batch
  • Collaborate more easily on scale-up, process optimization and troubleshooting
  • Prepare APRs and regulatory filings with 90% less time and effort