Regulatory
Accurate, Efficient Regulatory Submissions
You need to find the most direct route to regulatory submission and regulatory approval for your bio pharmaceutical / biotech product or medical device so you can to reach your market faster. Quintiles’ regulatory submission teams have guided and executed hundreds of successful submissions to the FDA, the EMEA and other national regulatory authorities.
Covering many therapeutic areas, our regulatory specialists and medical writers produce quality documents that are compliant with ICH (International Conference on Harmonisation) guidelines and global regulatory requirements.
Pulling Resources Together for You to Help with Regulatory Submissions Approval
We will partner with you to determine the most efficient pathway to get your product to market – and keep it there. Whether it’s Common Technical Document (CTD/eCTD) requirements or the latest European Directives, we help you design studies that are compatible with local regulations and produce valid results for your pharmaceutical, biotech product or medical device.
Available resources extend across Quintiles. Our regulatory submissions and regulatory approval teams can handle the preparation, validation, submission and maintenance of regulatory applications.
View our medical device and bio pharmaceutical regulatory solutions.