Featuring Regulatory Compliance Associates^® Inc.’s Dr. Sharon Ayd, this PharmTech webcast is designed to help guide pharma companies through the steps required to prepare the chemistry and manufacturing process information expected by FDA in an IND filing application.

The slides address 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.

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].