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United States Agent
B&H currently represents
over 25 international companies as designated US Agent.
We interact with FDA on our clients' behalf and 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
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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
- Labeling
- Drug listing and establishment registration
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