April 14, 2022 (Indianapolis, IN) – Galentis S.r.l. is pleased to announce the company has achieved ISO 13485:2016 certification for its design, development and contract manufacturing of intermediates for medical devices. As part of the process of obtaining the new ISO standard, Galentis’ quality and regulatory groups worked to harmonize the company’s existing standard operational procedures (SOPs) with ISO 13485 concepts, focusing on updating its quality policy and handbook.

The ISO 13485 standard supplements the ISO 9001 standard and is specific to medical device quality systems. ISO 13485:2016 was published in January 2016 and supersedes ISO 13485:2012. The new version of the standard was developed to harmonize with the EU Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC.

In addition to receiving the new certification, Galentis also maintains its ISO 9001:2015 certification and complies with Current Good Manufacturing Practice (cGMP) requirements.

With more than 30 years of experience in chemical synthesis and the production of advanced pharmaceutical intermediates and other fine chemicals, Galentis is committed to providing customers with the highest level of service. This new ISO certification further demonstrates the company’s ability to meet customers’ regulatory needs.

As the sole worldwide producer of Perchloryl Fluoride, the selective fluorination agent, Galentis stands as an industry leader in the manufacture of non-active pharmaceutical intermediates and fine chemicals. For more information, visit www.galentis.com.