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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