Remedial Actions

Descripción del servicio

Some of the services that our group provide in this Category are: 1. Response to 483 and Warning Letters 2. Response to Consent Decrees 3. Continuous Interaction with US FDA and/or other Global or Local Regulatory Agencies 4. Development of Planned and Unplanned Deviations 5. Remediation Project Management 6. Complaint Investigations 7. Recall Response 8. CAPA Investigations 9. Root Cause Analyses 10. Training 11. Qualified Personnel Recruitment 12. Direct Supervision and Continuous Assistance