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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55 North Gaston Avenue   Somerville, NJ 08876 USA     Tel: 908-704-1691   Fax: 908-704-1693    mail@bhconsultingservices.com