SynCo Bio Partners B.V. is licensed by the Dutch authorities for the GMP production of clinical and market supply of biopharmaceuticals (license number: 108716F). The manufacturing site has been licensed for the production of bulk drug substances and aseptic filled dosage forms since 1992. SynCo is regularly inspected by the Dutch regulatory authorities, the most recent inspection was in January 2010.  A copy of SynCo's GMP certificate is available on request.

In addition to EMEA compliance, its facilities have been inspected by a number of regulatory authorities in view of the licensed products that are produced and distributed across many countries and organizations outside of Europe, including the Korean FDA, Brazilian ANVISA and Health Canada authority.