De-mystifying the Pharmaceutical Industry with StartUp-OTC Venture

Paule Belony has had over 15 years Pharmaceutical industry experience. As head of Quality Assurance for a midsize nutritional supplement firm, she has successfully developed and established all of the business processes for the quality management system. She is experienced in hosting succesful regulatory and customer audits. She has conducted raw material and contract laboratory Quality system audits and, she has developed and implemented cleaning validation, process validation and equipment validation programs to help the firm meet its FDA regulatory requirements. Moreover, she has developed procedures for compliant documentation systems, calibration, maintenance programs as well as vendor qualification. I understand that in the pharmaceutical arena your Quality System is the most far reaching of all your business processes. Additionally, it’s the system on which you are most often scrutinized to determine the health and viability of your company. Our firm is poised to help you establish and maintain a healthy Quality System and provide expert guidance to make key decisions.