Quality Systems and Compliance Services
Uniphar offers end-to-end quality services through:
- Critical quality planning encompassing all stages of product development
- Implementing Quality by Design (QbD) principles throughout all critical development functions
- Continuously assessing quality through audits and tracking/optimizing Key Performace Indicators (KPIs)
Value
Achieving milestones while minimizing program risk
Identify, manage, and qualify vendors
Establish phase-appropriate quality standards
QbD to ensure quality data and documentation
Total quality management to achieve successful regulatory outcomes
“Without a standard there is no logical basis for making a decision or taking action.”
Joseph M. Juran
Quality Services
Quality System Planning
- Conduct procedure and system gap analyses
- Determine appropriate QMS for phase/purpose
- NDA readiness
GxP Training
- Program team training, including lab & CMC activities
- Establish complaint procedures
- Audit preparation – agency/pharma
Nonclinical and Clinical Study Compliance and Oversight
- Study-specific quality support tailored to needs
- End-to-end execution
- Manage vendors and IP logistics
CMC Support and Oversight
- Establish quality agreements with CDMO & testing labs
- Real-time problem identification & solutions
- Review executed manufacturing & testing records
- Support lot release
Audit and Qualification Support
Vendor Identification and Qualification
- GLP – preclinical, R&D assay development, PK/PD
- GCP – CRO, site selection, bioanalytical lab support
- GMP – CDMO, fill/finish, labeling, and stability support
Risk-based Vendor Management
- Initial qualification through interim requalification
- Management of ad hoc “for cause” audits to address GxP issues
- Global review of applicable regulations FDA, EMA, ICH Q10, etc
Validation Engineering Assessment
- IQ/OQ/PQ review of systems and equipment for CMC activities
- Support for electronic systems (eTMF, ClinSpark, lab management software)
e-QMS and Data Room Hosting
Oversight/Management of Controlled Documentation to Demonstrate Clinical and Manufacturing Process Compliance
- Facilitate due diligence activities by investors & business development
- Facilitate regulatory authority or 3rd-party audits
- 21 CFR Part 11 & GDPR compliant
- Document repository for controlled development and supporting materials
- Electronic storage to facilitate activities across time zones and geographies
- Cloud-based infrastructure that can be leveraged on PC or mobiles with end-to-end encryption and cyber security controls
- Real-time support for back-end, document troubleshooting and user support for client requests
Talk to a Quality Expert
Reduce quality risk across vendors and critical activities. Schedule a free 30-minute consultation with Uniphar to discuss your program stage, quality system needs, vendor oversight, and upcoming audits or milestones.
