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Selvita Group and Polfa Warszawa announce commencement of a collaboration concerning the analytical work necessary to prepare the registration dossier for a medicinal product. 


The scope of the project, commissioned to Selvita Group, includes development, validation and transfer of analytical methods for characterizing substances resulting from the degradation product of a complex formulation. Due to the intricacy of the project, studies will require the use of non-standard, highly specialized analytical techniques. 

"We are delighted that a company with such a rich history, experience and reputation as Polfa Warszawa decided to use our services - said Dr. Milosz Gruca, Director of Research and Development, a Board Member of BioCentrum which belongs to the Selvita Group. We hope that our cooperation will expand in the future, so that Polfa Warszawa will be able to concentrate on its core activities related to the production of drugs, and Selvita Group will be able to support it in the field of research and development.

"We hope that this will be the beginning of a long collaboration, which will allow us for prompt preparation of registration dossiers. This way we will be able to deliver new products to the market faster, for the benefit of patients." - said Ms. Karolina Pokorowska, Spokesperson for Polfa Warszawa SA 

The project covered by the agreement is implemented for the preparation by Polfa Warszawa of a medicinal product registration. All tests performed by the Selvita Group will be carried out in accordance with the requirements of the European Medicines Agency. Results of the work will be prepared in the CTD format, allowing Polfa Warszawa to directly use them in the documentation submitted to the Office of Registration of Medicinal Products, Medical Devices and Biocidal Products . 



Selvita Group is an innovative Polish company providing research and development services and IT solutions. We deliver comprehensive solutions for pharmaceutical and research companies targeted at lowering the cost of bringing products to market. The group also includes BioCentrum, which has been audited and qualified by the General Pharmaceutical Inspectorate in the field of therapeutical substance manufacturing for the physicochemical analyses of the substances and their certification.  BioCentrum’s offer includes services in chemical analysis (eg. development, validation and transfer of methods of API analysis, stability testing, dissolution profiles), protein chemistry (incl. analysis of amino acid composition and sequencing), in vitro preclinical studies (ADME) crystallography, and enzyme production. 

Polfa Warszawa SA is one of the largest and most known Polish pharmaceutical companies. Polfa Warszawa SA manufactures 140 formulations, which are exported to over thirty countries. Polfa Warszawa is a leading manufacturer of hospital drugs and cardiac preparations. Upper respiratory track clearing medicines, drugs  produced by Polfa represent nearly half the domestic market. Currently the company is at the selection stage of an investor who will finalize the ongoing privatization process.