CoQua Lab S.r.l.

CoQua Lab srl is an “innovative startup” and a “spin-off” of the University of Turin, affiliated with the Department of Medical Sciences of the University of Turin, and specifically with the Laboratory of Clinical Pharmacology and Pharmacogenetics.

The company was established to translate university knowledge and research activities into the world of work, as a “third mission” activity of the University of Turin.
For our “misison,” “vision,” business partners and activities please refer to our website: www.coqualab.it.

The Laboratory of Clinical Pharmacology and Pharmacogenetics, with which there is a close operational partnership (in addition to the aforementioned agreement), is certified for UNI EN ISO 13485:2012 (as well as UNI EN ISO 9001:2012 for “Design, development and application of assay methods for clinical analytes and drugs. Performing pharmacogenetic analysis”), and the services we could offer will be, among others, “Design and manufacture of in vitro diagnostics.”

In light of the new CE-IVD regulations that came into effect in 2017 (for which we are already aligned), we are able to CE-IVD mark new kits or RUO kits (even current CE-IVD kits that, if already marked, which will have to be re-branded over the next 5 years, as the new standard requires) by producing the technical dossier useful for the inspection visit that the EXTERNAL body will have to carry out before granting the CE-IVD mark (in fact, the old CE-IVD self-marking lapses).

We are also able to brand the instrumentation (upon delivery of specific documentation), but most importantly we can provide the service of clinical validation of your CE-IVD (mandatory and particularly relevant in the new standard), thanks to the possibility of handling infected (and non-infected) biological samples, and substances/drugs of abuse at our laboratories.

We can conduct clinical studies for you (by submitting the designs and documentation to the Ethics Committees ourselves) and have access, through the clinical studies themselves, to all samples of all diseases/diagnoses/drugs that may be of interest to you. Finally, we can also help you with FDA-related requirements.

Our partner laboratory is also AIFA-qualified for Phase I (Phases I-IV) clinical trials, and can perform the analyses for pre-clinical studies, also developing “ad hoc” analytical methodologies on all biological/tissue samples for drugs and/or other molecules of your interest by exploiting, in particular but not only, LC-MS technology.

We are able to perform all analytical activities pertaining to Cannabis for medical use (titration of active ingredients) and to “light” Cannabis (with various types of analysis).