discussing regulatory process

Regulatory Core

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