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The system for managing research and development projects in medicament regimens GMP GLP, GCP

The aim of this project is to promote research, development, manufacturing and control activities of cluster members in the of medicaments development in the post-discovery phase.

Participating members will create a common unit - Center for Quality Management System of GMP / GLP, Regulatory Affairs services and consulting / project management of preclinical and early clinical stage. Within the project model laboratories in Palacký University and UFR CAV will be arranged and certified. Priority will be given to techniques that are in the GMP / GLP procedures difficult to reach, i.e. NMR or XRD.

Other members will hava opprotunity to use consultancy services in implementing of quality system, managing theirs projects, processing of documentation in GMP guidance for preclinical and early clinical development phase at favourable terms.

In addition, members will be able to use the service of laboratories, certified within the project. Center will allow the cluster participants to continue in development of active substances, especially their control and testing. After that, results will be more acceptable by Medicament agencies. This fact significantly increases the value of such projects (the licensee doesn´t have to repeat tests, respectively quality of offered license is better assured).

There is considerable demand after certain techniques (e.g. NMR) under GMP. The Center will allow participants to receive the contract for Medicament Control under the GMP regime and GLP studies. The Center will enable manufacturers of chemical substances within the cluster to perform the control of these substances under GMP and thus significantly improve the application of their production in the development of pharmaceuticals.

The Project is co-financed by the European Regional Development Fund and Czech Ministry of Industry and Trade