Biologics product development requires navigating complex and often-changing regulatory challenges that vary with each part of the product's lifecycle and differ greatly from the regulations faced by those developing traditional pharmaceuticals.
Scorpius BioManufacturing takes a proactive approach to meeting these regulatory requirements. We work closely with CDMO clients to develop effective regulatory drug development strategies for advanced biological therapies from the earliest stages of product development through to market authorization.
With a robust team of regulatory experts, Scorpius BioManufacturing is well-equipped to support your product as it is developed, manufactured, and brought to market. Our staff is experienced with a number of different global regulatory agencies including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
They are prepared not only to evaluate and guide regulatory strategy, but also to represent clients in their interactions with regulatory bodies such as the FDA. You can feel secure knowing that Scorpius BioManufacturing's experts will act as guides and advocates as we work together to navigate any regulatory challenges that may arise during your product's manufacture and beyond.