Blog / 22.09.2015
Part of the POLISANO Group - the only group of integrated health services in Romania. The Polisano Pharmaceuticals factory, representing an investment of 67 million euros, has obtained the NAMMD authorization for conducting clinical trials in the field of medicine, on September 9th 2015, which enabled the inauguration of the Bioequivalence Centre, and the conduct of clinical trials.
After an investment of 2 million euros, the Bioequivalence work platform complements the Research and Development Department, which allows the development and production of high-quality pharmaceutical products, at affordable prices, at national and international level. The existence of bioequivalence studies for generic drugs is mandatory and without this last step of the research chain, it is not possible to launch generics on market.
The construction in which clinical bioequivalence studies will be conducted, was completed in December 2014.
Subsequently, experts and researchers with a broad portfolio of achievements in the field were contracted. Their achievements during the last year are:
- Sanitary Authorization of Clinical Unit, no. 57 / July 4th 2015 issued by the Department of Public Health - Sibiu
- ISO 9001: 2008 Quality Management System implementation for "Conducting clinical trials on medicines for human use", issued April 7th 2015 by "The International Certification Network" and SRAC - Bucharest;
- Certification "Good Laboratory Practice" no. 43 / June 16th 2015 issued by the National Agency for Medicines and Medical Devices - Bucharest;
- Authorization for the conduct of clinical trials in the field of medicines no. 274 / September 9th 2015 issued by the National Agency for Medicines and Medical Devices – Bucharest;
The Bioequivalence Polisano Pharmaceuticals Platform allows simultaneous admission of 26 subjects in 5 salons with a high standard of comfort, with monitoring systems and requested medical assistance standings, three consultation rooms, a sampling room, informed consent room, and also a room for medical emergencies occurred during clinical trials, endowed with modern equipment (manufactured by Nihon-Kohden, Drager, Riester, etc). The Bioanalytical Laboratory has the latest equipment according to laboratory standards from prestigious manufacturers such as Agilent, Eppendorf, Euritmic.
The platform flows, equipment performance, data generated and standard operating procedures underlying the activities of the department have been audited, obtaining good results and respective approvals needed to run the bioequivalence clinical trials.
The Polisano Pharmaceuticals Company develops various types of partnerships or conducts of clinical trials, for molecules developed both internally and by other pharmaceutical companies, following to establish collaborations with researchers and prestigious pharmaceutical producers, whose demands can be met by the new Bioequivalence Centre of Polisano Pharmaceuticals.