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Projects

Investigational New Drug Application (IND), Clinical Trial Application (CTA), IND amendments, Annual Reports, etc.​

1.

Orphan Drug Designation (ODD), Request for Orphan Drug Grant and Request for Cost Recovery

2.

Breakthrough Therapy Designation (BTD)​

3.

U.S. Agents for foreign entities​

4.

Administrative and operations support​

5.

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