Filing an Investigational New Drug (IND) application with FDA is a milestone for emerging pharmaceutical companies seeking to gain approval for clinical testing of innovative new therapies. The IND application process must be thorough and by the book; collecting and reporting the supporting chemistry, manufacturing, and control (CMC) information can be stumbling blocks in the path to IND approval.
This webcast is designed to help guide small- and mid-size pharma companies through the steps required to prepare the chemistry and manufacturing process information expected by FDA in an IND application. While the focus is on novel small-molecule therapeutics, the elements discussed will be useful background for large-molecule programs as well.
Experts discuss the application process and communications with FDA; identify required information about the quality, purity, strength, preparation, and stability of the drug substance and drug product; and explain the crucial analytical methods and validation processes needed for a successful filing.
Presented by PharmTech. Sponsored by Regis Technologies. Speakers include Carol H. Danielson, MS, DrPH (President of Regulatory Advantage International LLC), Sharon W. Ayd, PhD, MBA (Chief Scientific Officer and Sr. VP Pharmaceuticals of Regulatory Compliance Associates, Inc.), and Daniel Weissmueller (Director of Quality of Regis Technologies).