Quality & Regulatory
Trusted oversight for every stage of your U.S. product lifecycle
Backed by clinician-led, end-to-end expertise, every service we provide is grounded in real-world care experience — strengthening compliance, mitigating risk, and elevating patient outcomes.
Trusted Oversight. Confident Compliance. Simplified Execution.
Quality Assurance
- Third-party quality oversight and coordination
- Batch record review & release support
- Change control, deviations & CAPA management
- Compliance documentation and reporting
State Licensing Management
- New license applications & documentation preparation
- License renewals, change filings & jurisdiction monitoring
- Centralized license portfolio management & renewal alerts
- Monthly compliance reporting
Regulatory Intelligence & Support
- Strategic interpretation of FDA and state regulatory changes
- Regulatory communications support and compliance review
- FDA correspondence management & routing
- Regulatory strategy consultation and submission guidance
REMS Program Management
- Oversight of REMS requirements
- Vendor and stakeholder coordination for REMS compliance
- Documentation, reporting & operational support
- Customer Coordination
U.S. FDA Agent
- U.S. Agent for FDA communications and facility registration
- Management of FDA notices, inquiries, and correspondence
- Support for submissions including formatting and eCTD publishing
Clinical Trial Quality & Regulatory Support
- Quality review of study-related documentation
- Vendor oversight for clinical-trial–related GxP services
- Regulatory support for trial submissions and compliance
Vendor Qualification & Management
- Ongoing vendor performance monitoring
- Operational and regulatory communication management
- Oversight of third-party manufacturing and GxP vendors