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 U.S. IND applications, over - 157
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