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RohnerChem / Rohner AG Quality Management

Our Quality Management System is fully compliant with the requirements of ICH Q7a and ISO 9001/14001. We are regularly and successfully inspected by Swissmedic (the Swiss Agency for Therapeutic Products), SQS (the Swiss Association for Quality and Management Systems), and by customers. RohnerChem was successfully inspected by the FDA in the second half of 2007 and is now qualified to manufacture an API for the US Pharma market. All equipment is fully qualified and maintained according to cGMP. Validated planning systems for processes and equipment guarantee the highest standards of data traceability. Stability programs for APIs and intermediates can be offered in-house, where required.