Expert Interviews: Regulatory Support
The lack of agreed-upon regulations for nanomedicines makes it difficult for researchers and SMEs to translate their innovative nanomedicines to clinics and into the market.
PHOENIX-OITB provides support and guidance to its customers for the creation of the Investigational Medicinal Product Dossier (IMPD) of the nanomedicines under development. The value added from the clear, accurate and creatively proactive writing of the IMPD is indispensable through all stages of development.
Furthermore, the regulatory support also includes the definition of the development pathway to reach the clinical stage and obtain marketing authorisation thereafter, as well as the safety and toxicology tests necessary to support the different stages of development. It may also cover services related to orphan drug designation, paediatric investigation plan (PIP) obligations, and strategic considerations to accelerate development within the EU regulatory framework.
In this video, Daniel Garcia of BioNanoNet Forschungsgesellschaft mbH (BNN) describes the regulatory support offered within PHOENIX-OITB and how he could help customers of the Open Call.
