Regulatory Compliance

Prologue is committed to performing all services in compliance with Good Clinical Practices (GCPs), International Conference on Harmonization (ICH) guidelines and 21 CFR Part 11.

The compliance staff ensures uniform implementation of a quality management program which includes:

• Standard operating procedures
• Training
• Performance/compliance metrics
• Detailed quality control procedures
• Quality assurance activities.

Prologue has developed a comprehensive manual of clear, well-written, global SOPs which enables employees to adhere to all ICH GCP and FDA regulatory requirements. The SOPs allow for staff training and assure that activities are controlled and documented appropriately.

Prologue’s Regulatory Compliance staff provides issue-focused regulatory support in numerous areas including GXP compliance, corrective/preventative action plans, HIPAA, and privacy compliance, ensuring data generated in support of health authority applications meets requirements, etc.