Highest standards
ASM works strictly to the following standards: GMP, cGMP as well as ISO 9001 : 2015, ISO 13485 : 2016 and ISO 22716 : 2007. ASM can also offer services for CE registration for medical devices. ASM was audited in May 2015 by FDA and received approval i.e. FDA Registration (FEI-No. 3005439256). A second FDA audit took place in September 2017.
ASM has been licensed to manufacture the following medicinal products:
- pharmaceuticals and medicinal products in liquid form
- semi-solid pharmaceutical preparations
- sprays (aerosols)
- bulk manufacture
- pharmaceutical products for clinical trials
- products involving highly active or allergenic active ingredients
Processing of the following products is not included
- aseptically manufactured products
- biological products (immunological medicinal products, medicinal products involving living organisms)
