In our business there are too many things to take care of: time, cost, quality, science, compliance, technology, integrated support…
All those build and maintain the genotype of our company, which however is no more than a simple, single word:
What's in a name
The idea behind the name QualiMetriX is the combination of words Quality and Metrics (from the Greek μετρώ ”to measure”).It has been inspired by the basic concepts of Qualimetry1and reflects the mission of the company for quantifying the quality through scientific methodology.
Qualimetry designates a scientific discipline studying the theory and methodology of quantitative assessment of the quality of any kind of object. Quality is the object of Qualimetry as a field of knowledge.2
The logo of QualiMetriX depicts the entanglement of Q and M, which reflects our view that Quality and Metrics are the opposite sides of the same coin. Quality is meaningless without Metrics, while Metrics lack scientific sense without Quality.
1. Azgaldov, G. G., Glichev, A. V. et al., “Qualimetry: the Science of Product Quality Assessment”, Standartyikachestvo, 1968(1).
2. Azgaldov, G.G. (1981), “Development of the theoretical basis of qualimetry”, doctoral dissertation, Kuibyshev Military Engineering Academy, Moscow.
What we do
QualiMetriX is a Contract Research Organization.
QualiMetriX is focused on supporting pharmaceutical products throughout their whole lifecycle; from the development of the product to the manufacturing and post marketing stages. Services range from routine to highly complex projects; with full support given to the regulatory requirements and research challenges; and performance consistently taking place in an environment of Good Laboratory (GLP), Good Clinical (GCP) and Good Manufacturing Practices (GMP).
QualiMetriX comprises two active sites: the central laboratory and the innovation center. A third 3000 m2 site is under construction, which will include six state of the art laboratory units; sterile area; high potent lab and a high tech training center. The construction of the third site is expected to be completed within 2019.
The overall structure of the company consists of six scientific and three supporting departments.
THE CONTRACT RESEARCH ORGANISATION
QualiMetriX is a lifetime project that was born through years of experience and teamwork and aims to utilize the human resources, equipment and expertise for the benefit of pharmaceutical industry.
QualiMetriX staff comprise highly motivated research experts – graduated specialists with PhD and MSc, experienced in pharmacy, chemistry and related sciences.
Within the years of company’s operation, we have been involved in the approval of hundreds of pharmaceutical products worldwide and a significant number of studies have been performed on behalf of European and Global pharmaceutical companies.
Our ambitions for the future mainly apply at three levels:
- The technology: Implementation of state of the art instrumentation and robotic integrated systems in order to build up fully automated procedures which will reduce the manual handling to minimum. In parallel fully integrated and validated computerized systems will be adopted in order to attain an electronical, ultimately paperless, quality management system.
- The science:To expand our field of expertise to biotech products and advanced therapies.
- The impact to the pharmaceutical industry: To complete the construction of the high tech training center and provide training to young as well as senior scientists in the field. The company will act as a cutting edge and open source point, where information and know-how will be available to everyone. The community of QualiMetriX should widen and include fresh scientific brains, which by working in a high level scientific environment should have the opportunity to prove their potential and develop their capabilities, both for the benefit of the CRO as well as for the benefit of the end user; the pharmaceutical industry.
Who we are
Trained on ISO/IEC 17025 as an assessor and tutor by United Kingdom Accreditation Service (UKAS). Lead Assessor of the Hellenic Accreditation System (ESYD) since 1997, conducted assessments in over 300 Testing Laboratories. Member of the European Pharmacopoeia Committee since 1997 and scientific expert of the World Health Organization (WHO) on the quality control of drugs and the International Pharmacopoeia.
Quality expert in the chemical pharmaceutical products having served for several years in all parts of the field: as a regulator (in EMA); as an assessor (in the National Agency) and as a principal investigator (in the CRO). A former member of CHMP/QWP Quality Working Party of the European Agency of Medicines. Registered on the EMA database of European Experts and a former officer of the National Organization for Medicines/ Laboratory of Human Medicines.
Currently been assigned with the executive management, which among others includes the administration and development of the company.
Quality expert on chemical pharmaceutical products with integrated experience in the Pharmaceutical Quality System and products’ lifecycle management. Began his career as a Laboratory Manager in a company specialized in bioequivalence studies. In 2007 he joined the National Organization for Medicines, served as a Quality Assessor (initial approval and dossier variations) and as a member of the Laboratory of Human Medicines, a part of the OMCL network, conducting among others the post approval market surveillance. Since 2012, successively served all key positions in the field: as an RnD, Bioanalysis, Quality Control and Quality Assurance Senior Manager.
Currently been assigned with the development, implementation and management of the CRO’s new services and activities, related with the current scientific and industry trends, that line up with the overall mission and goals of the organization.
He joined QualiMetrix S.A in 2015. Began his career as a Laboratory Manager in a company specialized in Analytical R&D for pharmaceutical products. In 2005 he joined a Greek Pharmaceutical Company as the Analytical Development Manager and in 2006 he took over the Quality Control Operations as the Head of the QA/QC department. In 2007 he was appointed as the Qualified Person from the National Organization for Medicines. In 2011 an acquisition from a US based multinational company took place and in 2014 he became the Quality Operations Associate Director and the Qualified Person for the newly formed Quality Unit.
Since he joined QualiMetriX he has been assigned with the top management of the QA, QC and R&D departments and since 2017 designated as the Qualified Person.