Ensure full EU and global regulatory compliance for your medical products with expert guidance.
Overview
Regulatory deficiency letters require prompt, comprehensive, and scientifically sound responses to prevent approval delays. Globaxa’s deficiency handling services provide expert support in addressing health authority concerns efficiently and effectively, ensuring your products move forward in the approval process.
Comprehensive Deficiency Response Services
Deficiency Analysis
- Detailed deficiency letter review
- Critical versus non-critical categorization
- Root cause analysis
- Impact assessment on approval
- Response strategy development
- Resource allocation planning
Major Deficiency Handling
- Comprehensive gap remediation
- Study protocol development
- Contract research organization coordination
- Manufacturing changes
- Significant additional testing
- Long-term stability commitment