CANNABINOID QUALITY YOU CAN TRUST

  • 21 CFR Part 210 / Part 211 and ICHQ7 qualified manufacturer of API CBD isolate
  • Drug Master File # MF036798 registered at US Food and Drug Administration

IN CBD PRODUCTION, QUALITY + COMPLIANCE = TRUST

The rapid growth of interest in recent years has been extraordinary. Rapid growth can create challenges for companies seeking high compliance and quality assurance.

And that’s precisely where Averix Bio fits in. 

cGMP + ICH Q7 = API Products and DMF on File

If you’re looking for all the right compliance initials, you’ll find them here:

 21 CFR Part 210/Part 211 cGMP compliant
ICH Q7 compliant
EU GMP practices in place
DMF on file with the US FDA

BUILT FOR COMPLIANCE

Receiving. Warehousing. Staging. Extraction. Every material-flow aspect dynamic in our operations was examined during the design-build process to ensure API compliance. And a multidisciplinary team — including SMEs in Compliance, Process Flow, and Validation — keeps it that way through continuous monitoring, audits, and optimization.

THE TEAM TO TRUST

The Averix Bio team has more than 175 years of combined cGMP/pharmaceutical experience, and we have built relationships with specialty consultants with a broad range of compliance expertise (including, for example, CBD cryo-ethanol extraction). And since high-quality industrial hemp production requires a quality assurance system at an industrial scale, we collaborate closely with federal, state, and local authorities to ensure compliance with all ongoing legal requirements and guidelines.

QUESTIONS?

Let’s get them answered. We’re interested in learning more about how you’re using cannabinoids and how we can be an effective ingredient in your success.