Krakow, Poland – 15 February 2019 – Selvita, one of the largest drug discovery companies in Europe, announced that Selvita Analytical Laboratory GMP Certifications will be automatically recognized by the FDA from February 7, 2019.
Thanks to the mutual recognition agreement between the Food and Drug Administration and the European Union and a positive inspection in the Polish regulatory authority (Chief Pharmaceutical Inspectorate – Glowny Inspektorat Farmaceutyczny/GIF) conducted recently by the FDA, from February 2019 the Polish GMP inspections are considered equivalent to the FDA inspections which can rely on the Polish regulatory authority. This means that all experiments conducted in Selvita GMP-certified laboratories will be automatically recognized by the FDA without the need for additional inspection. This applies to all testing on the following products: human chemical pharmaceuticals, human biologicals, active pharmaceutical ingredients, intermediate products and bulk pharmaceuticals.
“We welcome the harmonization of inspections between the FDA and the Polish CPI. It is very good news for Selvita and our US. based clients for analytical services because it will be easier for them to take advantage of our GMP-certified outsourcing services testing without additional waiting for an inspection by the FDA.” – said Milosz Gruca, Director of Biology Department at Selvita.
Selvita S.A. is a clinical stage drug discovery company engaged in the research and development of novel cancer therapies, as well as provision of integrated drug discovery services. Selvita is headquartered in Krakow, Poland, with offices in the USA (Greater Boston, San Francisco Bay), and in the UK (Cambridge). Selvita has currently several projects at early or late discovery stage. Drug discovery clients of Selvita include numerous large and medium-sized pharmaceutical and biotechnology companies from the USA and Europe. The company is listed on the Warsaw Stock Exchange (WSE:SLV).
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