Trusted Oversight. Confident Compliance. Simplified Execution.
Backed by Globyz clinician‐led, end‐to‐end expertise, every service is grounded in real‐world care experience focusing on solutions that strengthen compliance, mitigate risk, and elevate patient outcomes.
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