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the Netherlands

Quality Management System upgrade at Tetris Pharma (NL)

PCS performed a QMS upgrade for Tetris Pharma’s GMP quality system.


Project summary

QMS upgrade to local (Dutch) regulatory standards.

Performing a Quality Management System upgrade for Tetris-NL to prepare the local organization for an upcoming IGJ inspection

Tetris Pharma, a subsidiary of Arecor Therapeutics plc, is a commercial-stage specialty pharmaceutical company specialised in registering, marketing, sales and the distribution of speciality hospital products across the UK and Europe.

Tetris Pharma Netherlands has a number of products, including Ogluo, a 1 mg solution for injection in a pre-filled pen.

To help Tetris Pharma (NL) prepare for a Dutch regulatory inspection, PCS provided a standard set of Quality Management System documents. These standard procedures were quickly adapted to Tetris’ process, standards and requirements.

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