Service

Allura Medcial Solution, Inc. provides comprehensive, hands-on cGMP Quality Compliance services to the Medical Device Industry.

The cGMP consulting services are characterized by:

• Preparing policies, quality standards and SOPs
• Reviewing batch records
• Planning, conducting and/or managing remediation projects
• Performing root cause investigation, progressing CAPA
• Planning and conducting mock FDA inspections
• Performing global supplier and vendor audits
• Identifying and closing data integrity gaps in a GMP environment
• Reviewing and improving management controls
• Identifying and assuring the “c” in cGMP
• Enhancing management controls
• Conducting oversight programs for senior leadership
• Reviewing and improving training resources
• Executing site-wide organizational improvement plans

Allura Medical Solution, Inc. provides peerless service of responding technique to the FDA inspection. Allura Medical Solution, Inc. responses to FDA inspector during the inspection term as a representative. Moreover, it is possible to provide the translation service during the FDA inspection (Korean only).

• Performing mock audits to evaluate compliance with regulatory standards
• Preparing and improving SOPs for GMP
• Conducting training in GMP, quality assurance and quality control
• Assisting in the preparation of responses to 483 and/or warning letters
• Liaising with the FDA
• Adverse Event Reporting
• Protocol Violations and Waivers
• Clinical Investigator Oversight
• Laboratory Data Collection Process