CoQua Lab S.r.l.
Via Ottavio Assarotti 10
10122 Torino (TO)

Contact person: Antonio D'Avolio
Role: CEO
Email: info@coqualab.it
Phone: +39 3389937305
Site www.coqualab.it

Founding Year: 2015
Employees: 2
Employees in R&D: 0
Fields of business: Pharma / Biopharma, Medical devices / Biotech Healthcare, Healthcare (Health Care Services and Suppliers)

Keywords:
Pharmacology, Toxicology, Pharmacogenetics, Chemistry, Clinical Biochemistry, Therapeutic Drug Monitoring, Clinical Studies, CE-IVD validation, Cannabis.

Description

CoQua Lab srl (www.coqualab.it) 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 with the Laboratory of Clinical and Pharmacogenetic Pharmacology.

The company was created to translate knowledge and university research into the work planet, as a "third mission" activity at 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 CoQua Lab has a close operative partnership (as well as the aforementioned agreement), is certified for the UNI EN ISO 13485:2012 (as well as for the UNI EN ISO 9001:2012 for "Design, development and application of determination methods for clinical analytes and drugs. Pharmacogenetic analyses"), and the services we could offer will be, among others, "Design and production of diagnostic medical devices in vitro".
On the basis of the new CE-IVD regulation (May 2017), we are able to mark CE-IVD new kits or RUO kits (even the current CE-IVD kits which, if already marked, which will have to re-mark within the next 5 years, as required by the new standard) producing the technical files useful for the CE-IVD mark. We are also able to mark the instrumentation (upon delivery of specific documentation).
We can provide the service of the clinical validation of your CE-IVD (mandatory and particularly relevant in the new regulation), thanks to the possibility to manage in our laboratories the infected (and uninfected) biological samples, and drugs/drugs of abuse.
Particularly, we can carry out clinical studies for your company (presenting the projects and documentations to the Ethics Committees) and access, through the clinical studies, to all the biological samples of all the pathologies/diagnoses/drugs that may interest to you. We can also finally help you in case of needs related to FDA regulations.
Our partner laboratory is also AIFA enabled in Phase I (Phases I-IV) of clinical trials, and can perform analyses for pre-clinical studies, also developing "ad hoc" methodologies of analysis on all biological / tissue samples for drugs. and/or other molecules of your interest, working, in particular but not only, with the LC-MS technology.
We are, finally, able to perform all the analytical activities related to Cannabis for medical use (titration of active ingredients) and cannabis "light" (with all kind of analysis).

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