As products evolve and change, so does the expertise required to develop them. We work with the new and growing field of therapeutics and diagnostics that are combination products, typically comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic. These products can be physically, chemically, or otherwise conjoined to produce a single entity; packaged together in a single package; or labeled in such a way that both products are required to achieve the intended use or effect.
Navigating the uncertain regulatory environment for these products is a difficult task, as they face unique issues and little guidance often exists from global regulatory authorities. Determining the primary mode of action of the product, the exact classification, and even the regulatory authority with jurisdiction over the product can seem daunting.
Our team understands the unique challenges of combination products and their associated regulatory requirements. We provide our clients with sound advice regarding their development, regulatory, and clinical strategies, and are able to successfully guide you through the regulatory ambiguities.
Our consultants can guide you through the entire process one step at a time.