Sarah Green, B.A., Photography and Digital Imaging

Joining Cyclomedical in April of 2014 to assist with conforming Standard Operating Procedures (SOPs) for the worldwide PET radiopharmaceutical facility business of the company, Sarah has found her skills well suited to the requirements of Regulatory affairs.  She subsequently earned a Certificate in Medical Product Quality from The University of Southern California’s School of Pharmacy, Regulatory Science Program, and has completed the course, GMP Auditing for the Pharmaceutical Industry, through the International Society of Pharmaceutical Engineers.  As an active member of the Regulatory Affairs Professionals Society (RAPS), Society of Quality Assurance (SQA), and the Southern Regional Chapter of the SQA, she keeps current with workshops held by RAPs, FDA, and SQA.

“Success is a team effort.”  Sarah works closely with Cyclomedical’s scientific and technical staff, both US and international, for a unique combination of expertise that helps ensure clients achieve and maintain compliance with current Good Manufacturing Practice.  That team provides site GMP audits for PET production centers across the US. Since early 2015 Sarah has been assisting clients with the Abbreviated New Drug Application (ANDA) approval process, overseeing the paperwork process from start to ANDA approval, including post-market requirements of approved applications.  She has also prepared numerous Site Master Files for clients.

Sarah is now qualified in preparing eCTD documents for submission to FDA on behalf of Cyclomedical’s clients.  With several years’ experience in working with regulatory consultants for FDA submissions, she has both the proficiency and strong organizational skills to maintain liaison with FDA and manage required documentation and filings.