According to Paragon's Founder and Chief Executive Officer, Gena Reed. "Regulatory expertise is a must in today's industry," said Reed. "Our staff has the drug development and medical device experience that is reassuring to our sponsors."
The Global Regulatory Affairs team at Paragon Biomedical comprises a diverse group of compliance professionals whose many years of experience in both novel compound and device program development, regulatory interactions, and submissions, provides sponsors with well-rounded, far-reaching expertise, worldwide.
New members joined the team in direct response to increasing demands for regulatory strategy, related to optimal country selection, compliance, and the management of complex global clinical trial regulatory services.
Marie Hanley, Executive Director, Global Regulatory and Quality Services at Paragon, said, "The delivery of rapid, global study startup requires not only a depth of hands-on global submission regulatory expertise and knowledge of local regulatory requirements, but the ability to do things differently. Paragon Regulatory has a track record of consistently meeting and exceeding projected submission timeframes in support of global clinical trials. Our ability to overcome regulatory submission challenges presented by regulatory authorities, study design, therapeutic areas, and patient populations, has been demonstrated. We anticipate and understand these challenges, and recommend strategies to mitigate and overcome, through our effective regulatory project management and expertise."
Regulatory changes in both the pharmaceutical and the medical device industries require dedicated and knowledgeable regulatory resources for proactive planning. Paragon's global regulatory capabilities assure sponsors receive the most current, therapeutically and product-aligned strategic regulatory information. Our expertise along with early collaboration allows our sponsors to make effective and cost-efficient decisions to move their development program forward.