Cannabis Science, Inc. (OTCBB:CBIS), a pioneering pharmaceutical cannabis company, is pleased to announce that it has formalized its agreement with a privately owned, highly specialized international FDA regulatory compliance firm. The compliance firm will review and prepare technical data for Cannabis Science's FDA Pre-Investigative New Drug (IND) submission package for its Veterans PTSD Project. The compliance firm will also participate in the Pre-IND meetings for regulatory guidance and interactions with the FDA throughout the approval process. In addition, the compliance firm will provide high-level expertise in the steps following the IND approvals, including technical and regulatory writing of validation protocols for a comprehensive drug development program.
Dr. Robert Melamede, PhD., Cannabis Science President and CEO, explained, "This contract is a concrete demonstration of our progress in moving our first new drug product through the FDA process. Our FDA specialists will also provide Cannabis Science with high-level expertise in the steps following the IND approvals, such as providing process validation for biological product design and analytical development for clinical trials. The compliance firm will conduct the oversight for implementing cGMP (current good manufacturing procedures) regulations, technical writing for the manufacturing processes and required compliance audits of quality systems integration of the biopharmaceutical drug development. We believe that there is an urgent need for cannabis based medicines, and our strategy of minimizing corporate bureaucracy is the fastest and most economical way to our goals."
Richard Cowan, Cannabis Science CFO, added, "Signing this contract with a company that provides expert guidance to members of the biotechnology and pharmaceutical industries worldwide gives us the support of a large staff of professionals, many with advanced degrees in the relevant fields that would be difficult and expensive to duplicate in-house. Dr. Melamede has again demonstrated that his standing in the scientific community is such that the very best people want to help our company develop its products."