We work exclusively in orphan drugs and advanced therapies. We advise, develop, write, review, and submit regulatory dossiers. Our regulatory team brings over 100 combined years of industry and consulting experience in orphan drug regulations and development. Made up entirely of Ph.D./MS-level/MD, senior regulatory strategists and mechanics, and all the passion in the world, they lead programs to success. Our Clients are those looking for strategic and operational support; someone who can be eyes-on and hands-on their program as and when needed; someone to help them navigate this complex regulatory pathway, and help them to decide when and how to submit their orphan applications, applications for accelerated approvals, and interactions with the Agencies. They hire us to incorporate data from the smallest of populations coupled with novel therapies into the purest blend of science, regulations, patient care, and corporate objectives. We help them to maneuver the product through the regulatory framework, steering the data into a regulatory position that is poised to accelerate into marketing as early as possible. They trust our team, as we continue to work fast and hard to ensure their success. We plan, formulate questions, write, review, and/or submit. ­ - Regulatory operations ­ - Strategy & Development ­ - Medical Writing ­ - Publishing Visit our website to hear what our clients are saying about us.