Regulatory Affairs

Regulatory Affairs

We have conducted extensive extractables testing as well as compendial and biocompatibility testing as per ISO, USP, EP and JP.Our company is works closely with regulatory authorities and sponsors on a worldwide basis to support drug submissions. Working closely with FDA’s Emerging Technology Group and under FDA recommended testing, the company has demonstrated a like-for-like equivalence to glass containers of the SiO2 containers.

SiO2 Materials Science’s state-of-the-art, 165,000 ft² facility in Auburn, AL USA includes a manufacturing plant with three clean rooms comprising a total of 40,000 ft². The company is building a second manufacturing plant in Switzerland. The manufacturing plant is registered to ISO: 13485 and 15378 and in compliance with cGMP, QSR and applicable CFR’s.

Regulatory Standards

  • Traceable with unique IDs
  • GMP certified manufacturing
  • Dry chemistry inherently clean
  • Sterilizable up to 136°C
    Passed compliance testing for ophthalmic products (USP 789)
  • We have registered Drug Master Files from regulatory bodies

Get in touch to learn more

We would love to discuss how SiO2 can be a solution for you. Contact us today. Contact SiO2