Cline receives SME status for conducting clinical trials

The decision is the first step in a process, by the European authority EMA, to certify Cline's method and intention to manufacture ATMPs (Advanced Therapy Drugs) for clinical use.

SME status also means that Cline as an organization can receive support and extra guidance to facilitate faster completion of clinical trials. In order to prepare and conduct clinical R&D, smaller organizations can be classified with a special status know as SME status. This status grants the support and scientific advice of EMA's experts.

Cline expects to receive extra guidance and cost reductions for among other things, the regulatory processor that Cline will implement in their projects.   

"This is an opportunity for SMEs to get an assessment of the data they have generated and verify that they are on the right path for successful development." - EMA

More about Cline

Cline Scientific develops advanced cancer diagnostics and regenerative medicine treatments. The company is working heavily with R&D through joint collaborations with pharmaceutical companies and academic researchers around the world. The focus is on projects in the cancerdiagnostic and stem cell therapy fields since Clines nanotechnology here provides unmet solutions to critical challenges and functions. The unique patented surface nanotechnology is used in cell-based products and processes to drive projects within Life Science into and through the clinical phase. 

Cline operates out of Gothenburg, Sweden and was founded in 2012 from a long-term research project in surface nanotechnology.

Cline Scientific AB  

Argongatan 2C
431 53  Mölndal

Telefon: 031-387 55 55 
E-post: info@clinescientific.com 
Hemsida: www.clinescientific.com