Dörner-Kernen

cGMP, ISO 9001/14001

Our Quality Management System is fully compliant with the requirements of ICH Q7 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 2011 and 2007. All equipment is fully qualified and maintained according to cGMP. Validated planning systems for processes and equipment guarantee the highest standards of data traceability. We also offer in-house services such as stability measurements (shelf-life etc.) for a wide range of chemicals, including organics, specialized chemistries (including cosmetic and electronic industries), as well for the life science industries including stability studies for API and intermediates.