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Regulatory Consultation Services
Vigilare has a demonstrated experience in international regulatory reporting requirements.
We Provide
- Strategy for Filing
- Review of ANDA Documents (Includes CMC documentation)
- Response to deficiencies – Regulatory guidance provided
- Labelling review
- Provide Document Checklist for ANDA preparation
- Support for ANDA document preparation/review/compilation
- Final Submission to FDA
- Deficiency Management post submission
- Management of ANDA Amendments
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