Remediation

RegDev is experienced in remediation planning, execution, and helping our clients implement solutions to meet global regulatory requirements. RegDev's Remediation services include:

• Risk Assessment
• Remediation Plan Development
• Project Planning and Implementation
• CAPA Development and Implementation
• Quality System Development
• Oversight of Contract Service Providers
• Quality Agreements
• Employee Development and Training
• Resolving and Executing Inspection Commitment
• Responses to and Remediation of official regulatory action (ex: 483s and Warning Letters)