|Cerbios-Pharma SA (hereinafter referredto as "Cerbios") is a Swiss privately held company located in Barbengo/ Lugano, Switzerland, specialized in the development and manufacturing of chemical and biological APIs for its partners world-wide.
cGMP APIs manufactured by Cerbios consist of small molecules (Chemical Division), large molecules and Probiotics (Biological Division) sold to pharma companies in highly regulated markets like Europe, North America, and Japan as well as in many other countries in South America and the Far East.
Services provided in both areas include all classical requirements for the registration, launch and commercialization of a product, such as technology transfer, process and analytical development and validation, regulatory support, patent services, and all other activities required for the production of clinical batches up to commercial supply.
Quality & Regulatory
Our cGMP quality assurance platform is based on international standards (e.g. ICH, PIC).
Our quality system supports partners with the registration of NCEs or NBEs at the US-FDA, EMEA, PMDA and other regulatory agencies.
Cerbios holds several active DMFs (US, EU, JPN) in CTD format and is regularly inspected by its partners, and authorities. The Swissmedic inspection held in December 2015 and the US-FDA in February 2014 (two inspectors for four days without a 483) fully confirmed the state-of-the-art level of our quality system.
The site has also received full accreditation from the Japanese PMDA.