Experienced in the Coordination, Writing, Review, and Approval
of all your Regulatory Documentation Requirements.
- Facility Registration Assistance
- Investigational New Drug Applications (IND) Preparation
- Coordination of New Drug Applications (NDA)
- Warning Letter and Form 483 Response Assistance
- Coordination of EU Clinical Trial Authorization (CTA)
- Coordination of other Regulatory Documentation for world-wide Registration
- Clinical Label Review and Approval
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