DS InPharmatics Senior Regulatory Affairs Consultant, Dr. Catherine Bernard joins the show to share her experience in regulatory affairs in the pharmaceutical industry and preparing dossiers associated with CMC. In this episode, Ed, Brian, Meranda and Catherine discuss breakthrough designations, the role of agencies such as the FDA, and future trends in pharmaceutical regulation.

005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard

FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.

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005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard

005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard