Development Expertise and Software to Get You To and Through the FDA
The results of successful R&D efforts in the life sciences industry are a broad set of complex documentation that tells a story about a drug or product. This documentation requires scientific, development, and regulatory expertise to clearly articulate the product potential while executing on the development strategy.
Successfully submitted over 157 U.S. IND applications
NDA 505(b)(1) Applications - 30
505(b)(2) Applications - 42
FDA Meetings Including All Types (A,B, and C) - 124
Served As US Agent - 61
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Successfully Submitted U.S. IND applications
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Supported Orphan Drug Designation Requests
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Worked on Breakthrough Therapy Designation Requests
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Pediatric Waivers and iPSP
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Special Protocol Assessments (SPAs)
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Small Business Waivers
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DMF Applications
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Generics (ANDA) Applications
Facet Life Sciences delivers expert development consulting services and document management technology to small pharmaceutical, biotechnology, and medical device teams. Our development consultants support your company goals as they:
Share Practical Guidance
Employ Proven Development Technologies
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Author Complex Compliance Documents
Facet Gemstone, a simple, secure, and compliant document management technology, can help your team:
Maintain Compliance
Effectively Manage Authoring, Review, and Approval Processes
