Certifications

We are certified by ISO 9001:2008, ISO 13485:2012, we work according to cGMP/QSR and are registered at the US FDA as an ASR manufacturer (Registration number 9276027). However, please note that we do not claim any compliance to either ISO or FDA standard with regards to design and development control, as we manufacture DNA oligonucleotides according to customer specifications and are therefore not involved in these steps.

Many companies in the business claim that they are cGMP compliant, and as there is no certification for this it is hard for you as a customer to conclude the correctness of such a statement. The best way to do so is to audit the company and see for yourself. You and your company are most welcome to examine our Quality System by performing an audit on-site.

Downloadable files

  • Scandinavian Gene Synthesis ISO9001.pdf Download
  • Scandinavian gene Synthesis-ISO13485.pdf Download