Confarma

Regulatory compliance

The Solvias Group comprises two Swiss sites of Solvias AG (Kaiseraugst and Basel) and one French site of Confarma France SAS (Hombourg).

Compliance of Solvias AG

Solvias AG is regularly inspected by the Swiss Association for Quality and Management Systems (SQS) for ISO compliance. The Solvias AG Quality Management System is based on business processes in compliance with ISO 9001:2008.

Solvias AG has been duly authorized by Swissmedic, the Swiss Agency for Therapeutic Products, to manufacture medicinal products. This authorization allows Solvias AG to perform pharmaceutical analyses and to manufacture active pharmaceutical ingredients (API) for use in clinical trials within the standard of Good Manufacturing Practice (GMP). The certificate is based on inspections performed in accordance with the requirements of good practice in manufacturing and quality control of the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) and the Directives of the European Commission.

The US Food and Drug Administration (FDA) successfully inspected Solvias AG most recently in March 2014. Accordingly, Solvias AG has been accepted and registered with the FDA as a test facility for analyzing pharmaceutical products. The registration number for the Solvias AG Kaiseraugst facility (DUNS 48 073 9627) is FEI 300 873 5083 for the Basel site (DUNS 48 586 2887) is FEI 3010164215.

In addition, the initial self-identification of the Solvias AG testing site in Kaiseraugst, as required by the Generic Drug User Fee Amendments (GDUFA), has successfully passed validation and has been accepted by the FDA. Solvias AG is fully committed to maintain this status and to annually reconfirm the required identification information to FDA.

Compliance of Confarma France SAS

Confarma France SAS offers services according to GLP, OHSAS 18001, ISO 9001, ISO 14001 and ISO 17025 standards. Confarma France is authorized by the ANSM for compliance to GMP. The US Food and Drug Administration (FDA) successfully inspected CONFARMA France SAS most recently in March 2014. The FDA registration number for Confarma France SAS (DUNS 49 273 8125) is FEI 3002806657.

In addition, the initial self-identification of Confarma France SAS, as required by the Generic Drug User Fee Amendments (GDUFA), has successfully passed validation and has been accepted by the FDA. Confarma France SAS is fully committed to maintain this status and to annually reconfirm the required identification information to FDA.