Have a look at this poster of siNPAIN where you can easily get an overview of the EU-funded project!
At Asphalion, we are the regulatory partners throughout the project, ensuring the compliance of the regulatory requirements for the development of the nanotherapeutics, establishing a regulatory roadmap at the start of the project that will be validated with the Innovation Task Force (ITF) of the EMA. The clinical development of the nanotherapeutics and CMC aspects will also have to be considered from the regulatory perspective. Finally, an ATMP classification request will be envisaged to have a clear regulatory definition of the nanotherapeutic product.
siNPAIN team is striving to develop an efficient therapy to improve the quality of life of people affected by osteoarthritis and reduce the high costs associated with this condition. The objective is to create a siRNA-combined advanced therapy, which will lead to more personalised treatment options for different stages of osteoarthritis. At Asphalion we are the regulatory partner throughout the project.
For further information, you can also contact us at: firstname.lastname@example.org