Regulatory guidance and mandates change often, and are not always clear cut nor consistent across geographies. Biorasi has the experience and the agility to help you stay ahead of regulatory challenges around the world.
Removing Obstacles on the Road to Approval
Staying in compliance with regulatory guidance and requirements for clinical trials can be challenging. Achieving product regulatory approval is even more so. The complexity of seeking multi-venue regulatory approvals has led the industry to agree that regulatory affairs and strategy is one of the biggest hurdles in running clinical trials.
Biorasi’s team has worked with regulatory agencies in the most highly regulated venues across the globe. We have developed a comprehensive approach where clinical development programs and individual studies are designed from the ground up to address the regulators’ requirements in order to achieve the highest your trial’s ultimate acceptance and success. So whether your goal is to get a novel product approved by a single regulatory authority, such as the FDA, or a set of biosimilars approved by FDA, EMA and others in one global program, our expert team will guide you through the evolving regulatory maze throughout your journey to approval.