BOLDSCIENCE launches BOLDAPPROVALS division
December 12, 2023 | FDA AdComms, Pharma, medcomms, regulatory
BOLDAPPROVALS, a new division of the medical communications agency BOLDSCIENCE, will help pharmaceutical and biotech clients gain regulatory approval with comprehensive services that include preparation for US Food and Drug Administration (FDA) Advisory Committee meetings. BOLDAPPROVALS has a differentiated offering of experienced communications consultants, scientific specialists, and a cutting-edge digital platform.
BOLDSCIENCE has today announced the launch of its new BOLDAPPROVALS division. With a highly seasoned team, BOLDAPPROVALS helps clients succeed at the most critical juncture of the product lifecycle – regulatory approval, by providing support for FDA Advisory Committee meetings (AdComms), submission messaging, labeling strategy, and health authority interactions.
Mark Lydiatt, CEO and Co-founder of BOLDSCIENCE, commented on the new venture, “We’ve put together an experienced, multidisciplinary team that blends scientific expertise with communication consulting to create powerful bespoke solutions to surmount the biggest hurdles in the approval process.” He says, “With the addition of BOLDAPPROVALS, BOLDSCIENCE now supports clients at every stage of the product lifecycle, from discovery and clinical development through submission and approval to launch and commercialization.”
BOLDAPPROVALS is led by Steven Cohen, EVP and Managing Director at BOLDSCIENCE. Their core services will be AdComm preparation, submission messaging, labeling strategy and planning, and FDA interactions. Steven commented, “BOLDAPPROVALS expands on my 31 years of experience preparing more than 110 global teams for FDA Advisory Committee meetings and supporting numerous FDA submissions, health authority meetings, and other communication challenges.”
BOLDAPPROVALS is a team of experienced consultants and scientific specialists who drive an integrated approach to communication strategy, content, and delivery. In addition, the team is made up of project managers, PowerPoint specialists, graphic designers, AV engineers, IT specialists, and software developers. “BOLDAPPROVALS is a world-class team who, between them, have prepared more than 200 teams for live or virtual AdComms– I’ve never seen a team better positioned to help clients attain their goals,” commented Steven.
To support its AdComm preparation service, BOLDAPPROVALS has developed proprietary strategy tools, advanced slide management and switching systems, a suite of virtual meeting technologies, and a custom-made collaboration portal. “Our clients will not only have access to state-of-the-art tools to enable their preparation and delivery, virtually or in person, but also the powerful new CoLabPortal to organize and access all their slides, Q&A, and resources at the touch of a button,” said Steven.
To learn more about how BOLDAPPROVALS can help your team advance to product approval, please visit boldapprovals.com, email info@boldapprovals.com, or call Steven Cohen at +1 (646) 930-0453.
This content was provided by BOLDSCIENCE