List of Contributions

Assure Infusions is building a 60,000 sft state of the art pharmaceutical manufacturing facility in Central Florida. We are seeking an experienced regulatory affairs professional with substantial experience in drafting and submitting ANDA applications to FDA. The right candidate will have demonstrated ...

Hi All What is the FDA requirement for reuse the pure water coming out from a super-Heated sterilization (121 °C)system  in a Pharmaceutical facility manufacturing IV Bag and how many times can we use before replace that water, is it every 8 hours shift or per day or per batch ------------------------------ ...

Hi All,  Our company is about to start a new project to manufacturing IV bag making, Filling and sealing , could anyone advise what is the regulation to control this process and FDA requirements  Thanks ------------------------------ YASSER ESTAFANOUS Chief ofQuality & Regulatory officer Winter ...

Hi everyone, we are working in a UV sanitizers system and according to EPA regulations consider the UV system as a Pesticide device and all claims on the retail box, User manual and website should be legally and not misleading, So we need to have a consultant to send him/her all our printing and labeling ...

Does anyone know what is FDA Post-Market Study for conditions of Authorization? and can anyone send me a template   ------------------------------ YASSER ESTAFANOUS Director of RA/QA Winter Haven FL United States ------------------------------