Special products need special attention from people who understand. Orphan medicinal products (OMPs) almost always falls into this category. OMPs can be life-saving treatments but their development is often fraught with difficulty. Taking an OMP to market requires specific knowledge and expertise.

Kinesys has worked extensively on the development and registration of a range of OMPs across a broad range of rare diseases.

At Kinesys we appreciate the development, regulatory and commercial challenges associated with developing OMPs and we advise on expedited development pathways for these special products.

We fully understand what constitutes a robust Orphan Designation Application and have significant expertise in constructing well written and concise arguments to support key areas such as medical plausibility and significant benefit.

We intimately understand the requirements for Significant Benefit – often a prerequisite for Orphan Designation specific to the EU – and for maintaining Orphan Designation at the time of the MAA, an increasing challenge under the evolving legislation.

Our team of experts is continuously appraised of current and possible future legislative changes around the designation and approval of OMPs, and the implications of these changes. Kinesys has good relations with key members of the Committee for Orphan Medicinal Products (COMP).

Experience of presenting complex arguments at Oral Explanations to the COMP, resulting in successful outcomes for our clients.

Kinesys also has a successful track record with Orphan Drugs at US FDA.