Effectively Navigating Your Project
Regulatory staff experienced with the nuanced FDA approval pathway for biotherapeutics are available to assist with the development and implementation of pre-meeting packages and IND applications. Utilizing extensive knowledge of the pre-clinical development pathway, interconnectivity with other service providers in the center, a wide array of industry contacts, and uncompromising attention to detail, our regulatory core moves applications efficiently through the FDA pipeline. As a result, this core has established an unblemished track record of successful pre-meetings and approved Investigational New Drug (IND) applications for biotherapeutic products with the U.S. Food and Drug Administration. Hourly consultation rates for pre-clinical product development, FDA interactions, and IND application development are available.
For more information or to get your project started, contact:
William (Bill) Gruenloh