Highest Quality Standards
Strict adherence to the highest quality standards defines who we are – from the manufacturing of oligonucleotides for R&D to commercial manufacture and analysis of oligonucleotide APIs and drug products.
For our clients’ patients and with our common vision of a safer and healthier world in mind, we consistently comply with Good Manufacturing Practices (cGMP) as regulated by the German authorities, FDA, EMA and PMDA.
Covering the Entire Drug
Quality System for Commercial and Clinical Therapeutic Oligonucleotides
Since 2007, our manufacturing facilities and analytical laboratories have been cGMP-certified by German authorities. Our commercial cGMP quality system strictly adheres to the cGMP standards of regulatory agencies, such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA).
In 2016, we successfully completed our first FDA pre-approval inspection (PAI) 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 FDA and PMDA.
Quality System for Commercial Diagnostic Oligonucleotides
We are ISO13485- and, 9001-certified and FDA 21 CFR 820-compliant. Our quality system ensures the consistent quality that is necessary for the manufacture of commercial diagnostic oligonucleotides.
IND/IMPD and NDA/MAA Filing Support
As one of the most experienced CDMOs in the therapeutic oligonucleotide industry, we at BioSpring help our clients to succeed with their regulatory filings.
Driven by our technical and regulatory experience we provide CMC support for sections 1 to 7. BLA-filing assistance/support can also be offered.