The benefits of an experienced team for your unique CDx product
Today, there is limited regulatory guidance outside the US related to companion diagnostic (CDx) development and registrations. Beaufort can partner with you to co-develop your CDx product alongside a therapeutic with proactive planning and problem-solving that aligns with your specific needs. Our regulatory and quality assurance solutions comprehend regional and cultural best practices from across the globe.
Regulatory Services
- Regulatory strategy development
- Performance validation and risk determination
- Pathway assessment and planning
- Clinical Trial Assay (CTA) development
- Analytical study planning
- Protocol design
- Regulatory submission management
- Post-market support
Quality Assurance Services
- Harmonized CDx standard operating procedures (SOPs)
- Quality management system reviews, updates, and compliances
- Mock audit
- Inspection support
European Union In Vitro Diagnostic Regulation (IVDR) and CDx
The implementation of regulation (EU) 2017/746 (IVDR) has significant implications for the regulation of CDx, including a shift from self-certified general devices under the previous In Vitro Diagnostic Directive (98/79/EC) to high-risk class C devices under the IVDR. Performance study (clinical trial) requirements for CDx under the IVDR are also extensive. Most performance studies involving CDx products are subject to the same requirements as those for interventional studies.
The Beaufort Roadmap
A thorough and systematic approach to strategy and planning is critical for CDx approval during this time of transition. Beaufort can guide this process through a comprehensive gap analysis and conformity assessments that clearly identify and prioritize the areas of need, including:
- Gap assessments and gap fill strategies
- Requirement definitions and strategies
- Annex XIV applications
- Define, develop and draft essential study documents, including:
- Clinical performance study protocol (CPSP)
- Investigator’s brochure (IB)
- Informed consent form (ICF)
- Development of safety recording and reporting process(es)
- Quality system support
- Technical documentation support and preparation
- Intended purpose development
- Classification and coding
- Conformity assessment
- Design and manufacturing information
- General safety and performance requirements (GSPR) conformity assessment
- Benefit-risk analysis and risk management
- Product verification and validation
- Performance evaluation planning and reporting
- Analytical performance
- Clinical performance
- Clinical performance study plan
- Scientific validity
- Post-market surveillance
- Labeling
- European database on medical devices (EUDAMED) support
- Device and actor registrations
- Basic unique device identification (UDI), UDI device identifier (UDI-DI), and UDI production identifier (UDI-PI)
- EMA consultation procedure guidance