FMD K&L is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our partners. K&L was established in the US in 1995, and has grown to more than 1,400 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region.
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FMD has successfully hosted a webinar titled “Leverage the Favorable Regulatory Reforms in China to Accelerate Global Drug Development Programs“. Dr. Dan Zhang, Executive Chairman of FMD, and Emil Fu, SVP International Integration of FMD, discussed the regulatory reform in China and the strategies biopharma companies can take to make your programs more efficient.
The U.S. Food and Drug Administration (FDA) is now requiring that studies initiated after December 17, 2016 be submitted in New Drug Applications (NDAs), Biologics License Applications (BLAs) and Abbreviated New Drug Applications (ANDAs).
The implementation of electronic data standards advances FDA efforts by enabling more timely and effective regulatory reviews of submissions and their corresponding data. This white paper describes the evolution of relevant standards and provides recommendations for best practices in planning and preparing FDA submission data packages.
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FMD K&L hosted our annual company picnic on June 15, 2019 at PeaceValley Park in Doylestown, PA. Events like this are fun and they also help build team camaraderie and increase morale.