VST has the contacts and the knowledge to maximize your chances of success with regulatory authorities around the world. Our international team offers expert strategic advice and produces high-quality submissions, giving you access to the widest possible market in the shortest possible time.
Our experience encompasses international clinical trial approvals, registrations of new chemical and biological entities, and the development of new medicinal products. We devise and implement high-level regulatory strategies, expedite the registration of new drugs and biologics, manage all aspects of generic submissions as well as post-approval activities. For smaller organizations, we often serve as a virtual regulatory department, providing expertise as required while avoiding the expense of full time staff.
VST helps clients proactively meet regulatory and drug safety requirements throughout their product’s lifecycle. Our holistic, risk-based approach addresses every stage of clinical trial activities, from initial protocol design to study reporting.
Working on a national and global scale, our experts can devise an entire system or enhance your existing program with specialized expertise. Whatever your stage of development, SRA can help you make the right commercialization choices for your product.