From concept to market, we can meet your ever-increasing needs in regulatory, safety and compliance.
As a new era evolves at the FDA, formal meetings and interactions with regulators are increasingly necessary throughout the development paths of both drugs and medical devices. Whether your product is in pre-clinical development or being tested in clinical trials, or you are seeking to expand the reach of your already-approved product through labeling expansion, transparent yet nuanced engagement with regulators is key for regulatory success. Robust and efficient preparation for engagements with regulators is paramount to reduce delays in agency decision making.
At IQVIA, our Regulatory Science and Strategy (RSS) team is dedicated to guiding your products through the complex regulatory landscape. With a focus on drugs, biologics, and medical devices, we have leveraged real-world evidence to support over 35 indications. As a team comprised predominantly of former FDA experts, RSS approaches regulator interactions through the lens of the regulator to bring unparalleled experience in leading regulatory engagements across divisions and countries. RSS has a 100% success rate in obtaining formal meetings with regulators for Sponsors.
Download our factsheet to lead how IQVIA can help navigate the regulatory landscape with confidence and precision.
From concept to market, we can meet your ever-increasing needs in regulatory, safety and compliance.
Meet your clinical, economic, and regulatory needs throughout a product's lifecycle using U.S. real world solutions.