Regulatory Support

Ensure Compliance with the Requirements of Governing Agencies

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

For additional information on GBC’s consulting services please contact consulting@globalbioclinical.com or register and send us your inquiry here.