Our Approach
CompliScience Solutions provides support for the selection, oversight, and management of Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Organizations (CTOs) supporting biopharmaceutical, biologics, cell and gene therapy, and advanced therapeutic programs.
Outsourcing critical development, manufacturing, and testing activities does not outsource regulatory accountability. Sponsors remain fully responsible for product quality, data integrity, and cGMP compliance.
We help clients establish robust, defensible CDMO/CTO oversight frameworks that ensure external partners operate in alignment with regulatory expectations, contractual obligations, and product-specific risk profiles.
Our team brings hands-on experience leading MS&T, CMC, QA, and QC organizations in contract environments, managing multi-vendor manufacturing networks, and supporting FDA inspection readiness across outsourced programs.
We integrate scientific understanding, risk-based oversight, and practical governance into every aspect of external partner management.
Our support includes:
oCDMO/CTO selection and technical due diligence
oQuality agreement and governance framework development
oTech transfer strategy and execution support
oOversight models and performance metrics (KPIs)
oDeviation, OOS, and change control coordination
oAudit planning and execution support
oData integrity and compliance monitoring
oInspection readiness for outsourced programs
Rather than reactive vendor management, we implement science-based, proactive oversight that reduces risk, improves accountability, and protects regulatory credibility.
The result is a coordinated, inspection-ready outsourcing strategy that supports reliable development timelines and long-term product success.
