There is no doubt the Sarbanes-Oxley Act and the introduction of the Risk Evaluation and Mitigation Strategies (REMS) have dramatically changed the pharmaceutical landscape by adding a new level of complexity to the drug commercialization process. CuraScript’s comprehensive approach to risk management utilizes established compliance processes and policies to monitor, identify and remediate potential risks to support your product’s risk management effort.
CuraScript SD offers the expertise and proven experience to help you navigate the hurdles of REMS program design, implementation and management. We offer a complete portfolio of services and extensive experience supporting REMS program initiatives.
These initiatives include:
In addition to supporting REMS distribution programs, through our CuraScript specialty services organization, we are able to offer an integrated end-to-end solution with a full suite of services including reimbursement and patient assistance, as well as a comprehensive web solution.
While CuraScript SD can work with you to customize a procedure for reporting adverse events, our specially trained Customer Support team is trained to direct customers to the pharmaceutical manufacturer’s hotline, should an adverse event be reported to CuraScript SD.
In the event of a product recall, CuraScript SD’s state-of-the-art automated communication system ensures the rapid notification of product recall alerts to the affected customers. Our automated system can provide end-to-end support including automated recall notification to customers, product quarantines and reporting.
In the unlikely event of a loss or theft of product, our specially trained compliance team will work with you and the appropriate authorities to perform a complete investigation of the loss.
