United States Agent 

Represent international companies as the designated US agent; provide general regulatory affairs support, as needed. Tasks conducted on behalf of the sponsor include, but are not 
limited to:

• Assist sponsors in regulatory strategy development and implementation  
• File Orphan drug applications  
• Prepare, review and submit initial IND Applications  
• Assist in FDA negotiations on preclinical and clinical study requirements  
• Prepare, review and submit subsequent amendments (CMC, clinical, pharmaco-toxicological), general correspondence, responses to requests for information, safety reports
• Prepare and coordinate meetings (pre-IND, end of phase 2, pre-NDA) between sponsor and FDA
• Submit requests to FDA for fast track review  
• Compile, review and submit drug master files and subsequent updates, as required
• Compile, review and submit original New Drug Applications
• Coordinate activities to gain FDA approval of marketing applications  

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