Experts in Risk Evaluation and Mitigation Strategies (REMS)
REMS are required to support commercialization when the FDA deems it necessary to ensure that the benefits of a product outweigh its risks. TheraCom fully develops and implements REMS services and regulatory support, with a particular focus on commercialization strategies. Bringing the REMS to the marketplace, our goal is to maximize the impact of the risk management strategy while the minimizing the burden imposed upon health care professionals and hurdles to patient access. Our services include branded service models, customized services, real-time information management and drug-safety/regulatory support. We specialize in creating positive patient and prescriber relationships while fully complying with REMS requirements.
REMS compliance that creates positive patient and prescriber relationships
TheraCom also integrates comprehensive data reporting into the REMS commercialization strategy. This allows our manufacturer clients to meet FDA requirements for tracking, monitoring, and data reporting throughout the commercialization process in a seamless fashion. TheraCom works with the designated specialty pharmacy network to understand and implement REMS requirements at the point of care. From implementation planning through the development and execution of required data reporting, we manage the entire process to ensure specialty pharmacy compliance with data reporting requirements. We also assist our clients in meeting FDA reporting requirements.
TheraCom services in support of REMS requirements include the management of: