Since 2007, BioSpring is GMP certified by the German authorities for the manufacturing and quality control of therapeutic oligonucleotides according to ICHQ7. In 2016, we successfully completed an FDA pre-approval inspection for an analytical oligonucleotide program. In average, more than 20 customer audits per year are conducted at our GMP facility. Our advanced and proven GMP system covers all relevant aspects of API manufacturing for oligonucleotides used in clinical and commercial programs. We provide CMC sections for IND/IMPD filing and NDAs.
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