Capabilities
Regulatory & Quality
Efficient Strategies for US & EU Governing Agencies
US & EU Regulatory Strategy and Compliance
GBC supports clients in preparing for and complying with the requirements of governing agencies throughout the clinical research and product development cycle. GBC regulatory support services include:
Bioethics Support
- Develop Patient Informed Consent (PIC) Templates
- Ensure Compliance with Privacy Policies
- Data and Biospecimen De-Identification and Anonymization Schemas
- Compliance with Health Insurance Portability and Accountability Act (HIPAA)
Institutional Review Board (IRB) and Ethics Committee (EC) Support
- Manage Initial Protocol Submissions, Reviews and Approvals
- Coordinate Individual Investigator and Site Approvals
- Re-Submissions and Re-Approvals
- Manage Protocol Revisions and Amendments
- Report Serious Adverse Events (SAE) if Necessary
U.S. Regulatory Support (Medical Devices)
- Investigational Device Exemptions (IDE)
- Premarket Approvals (PMA)
- 510(k)s
EU and International Regulatory Support
- International Ethical Committee Submissions, Reviews and Approvals
- Support for Interactions with Notified Bodies and Competent Authorities
- Ministry of Health Coordination
Quality Assurance
GBC provides Quality Management System (QMS) and internal/external compliance auditing services to ensure that your research and development efforts are properly executed and documented according to applicable GxP and regulatory standards. GBC works with established and newly formed Quality Assurance (QA) groups to develop, review, and enhance quality system policies and procedures along the path for continual improvement. GBC quality management services include:
Quality Management System (QMS) Development
GBC supports the development, review, and enhancement of Quality Management Systems (QMS) and associated documentation including:
- Company Policies
- Standard Operating Procedures (SOPs)
- Training Processes and Documentation
- Clinical Trial Processes (Qualification, Initiation, Monitoring, Close Out)
- Biospecimen Management Processes (Collection, Processing, Storage, Distribution)
- Data Management Procedures
- Material, Supply, and Equipment Specifications
- Equipment Monitoring, Maintenance, and Calibration
- Technical Work Instructions
- Laboratory Instructions
- Batch Records
- Software Usage Instructions
- Customer Service Processes
- Operations Manuals
- Process Deviations
- Corrective Action and Preventive Action Procedures (CAPA)
- Management Review
Audit Services
GBC provides internal and external auditing services. GBC performs critical reviews of processes and associated documentation to provide results and analysis that help clients assess compliance levels and ensure applicable standards are met. GBC compliance and auditing services include:
General Auditing Services
- Preparation of Audit Plan
- Review and Organization of SOPs and QMS Documentation
- Review of Staff Training
- Review of Procedures
- Documentation of Observations and Deviations
- Preparation and Delivery of Audit Report
- Guidance for Resolution of Observations and Deviations
Internal Auditing
- Trial Master File (TMF) Audits (Clinical Studies)
- Data and Database Integrity Audits
- Inventory Audits (Investigational Materials, Biospecimens, Supplies, Equipment)
- Technical Process Audits
- Support for Certification Audit Preparedness
Clinical Site Auditing
- Sponsor Protocol Compliance
- Regulatory File and IRB Approval Audits
- Contractual Agreement Terms
- Internal Site Standard Operating Procedures (SOPs)
- Compliance with Sponsor Requirements
- Adverse Event (AE) Reporting
Lab and Vendor Auditing
- Organizational Structure and Personnel
- Ensuring Appropriate Experience and Resources
- Standard Operating Procedures (SOPs)
- Facilities and Equipment
- Equipment Monitoring, Maintenance and Calibration Records
- Data Collection and Handling Procedures
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