We can assist with enforcement actions by developing long-term strategies that will help your organization maintain compliance through continuous process and system improvements. Impact analysis and risk assessment activities can include but are not limited to:
- Developing strategies and define tactical actions for GMP areas to regain compliance with US FDA and other regulatory bodies.
- Development of Training Modules for comprehension to various parts of the regulations
- Data integrity assessment
- In-depth 6 System Audits & recommendations for improvements
- Supplier Quality programs & Quality Agreements
- Auditing services to verify any non-compliance gaps across manufacturing operations and supporting quality functions
- Quality Systems: Quality Control, Quality Assurance, Document Control, Complaint Handling, Investigations & CAPA’s, Batch Record Review & Release
