Commmercial quality and regulatory systems (GMP-certified, FDA-, EMA-, PDMA-registered)
BioSpring‘s commercial facilities and GMP system (ICHQ) are FDA- and EMA-inspected for the manufacture and analytics of therapeutic oligonucleotides.
Since 2007, we are GMP-certified by the Germany authorities for the manufacturing and quality control of therapeutic oligonucleotides according to ICHQ guidelines.
→ GMP Manufacturing Certificate
→ GMP Analytics Certificate
In 2016, we successfully completed our first FDA pre-approval inspection for an analytical oligonucleotide program. As of 2020, BioSpring is a commercial, FDA-inspected manufacturer for oligonucleotide APIs.
In addition, we are a registered API manufacturer with the PMDA.
→ Certificate of Registration FDA
→ Certificate of Registration PMDA
BioSpring is ISO13485, - 9001-certified and FDA 21 CFR 820 compliant. Our quality system ensures the consistent quality that is needed for commercial diagnostic oligonucleotides.