Novella Clinical’s Regulatory Affairs department provides comprehensive international support to our customers. Offering both operational and strategic consulting services, our team is experienced in interacting with Health Authorities worldwide.
Our regulatory and reimbursement experts include former sponsor and industry-trained professionals who provide guidance to sponsors as they navigate the constantly evolving international regulatory landscape. We work with our customers to develop smart and efficient regulatory strategies followed by effective regulatory submissions.
If your program does not require full-time regulatory affairs support, Novella provides strategic consulting services. Our team will customize a package with the specific deliverables your project needs.
Our Regulatory Affairs & Consulting Services Include:
- Global regulatory submissions and liaison activities, including meeting planning and briefing package development
- Clinical development planning and cost analysis
- Protocol or Clinical Investigational Plan (CIP) development
- Regulatory assessments (US, Europe, and Asia Pacific)
- Reimbursement strategies
- Report of prior investigations
- Agency audit support and warning letter resolution
- SOP development
- Device classification/predicate device searches
- Import/export requirements and management
- Creation of technical design files
- Clinical evaluation reports (CER)
- BIMO inspection support
- Post-market support