Connecting ideas
Bridging data to compile unique products
Research and Development
> Development of analytical methods
> Reverse engineering/ Investigation of the
reference product composition
> "Essential similarity” establishment for generics
> Dissolution development
> Skin Permeation Studies
> Extraction studies for primary packaging
and manufacturing materials
> Elemental impurities (ICH Q3D guideline)
> Development of analytical methods
> Reverse engineering/ Investigation of the
reference product composition
> Essential similarity” establishment for
generics
> Dissolution development
> Permeation studies
> Extraction studies for primary packaging
and manufacturing materials
> Elemental impurities (ICH Q3D guideline)
Validation activities
> Validation of analytical methods
> Forced degradation studies
> Leachables testing
> Cleaning validation / PDE establishment
> Stability studies
> Filter validation
Quality Control / Post approval services
> Batch Testing/ Release of API’s,
Excipients, Packaging and Final Products
> QP services
> Post approval (ongoing) stability studies
> Post Approval Management/ Lifecycle
strategy
Medical Devices
> Regulatory Affairs
> Cytotoxicity testing
> Sensitization Testing
> Irritation Testing
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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 to be 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.