Regulatory

Regulatory Services

Testing to Ensure Quality

At RNA, we want to ensure the products we manufacture do not run into legal or other regulatory issues that would prevent them from reaching market. And as a full turnkey contract manufacturer, we want to take that hassle off the backs of our partners. That is why we employ a robust team of regulatory experts with decades of experience working with retail, national, and international standards for quality.

Our regulatory team stays up-to-date on changing laws around the world and constantly work to update our chemicals used in our formulations based on the latest standards. They're able to produce documents for new product registration in countries across the globe, including the EU, Middle East, Africa, and Asia.

When it comes to product testing, RNA helps coordinate FDA testing for batch validation and active ingredient testing for over-the-counter formulations. We can also facilitate outside testing protocols such as Human Repeated Insult Patch Test (HRIPT) and SPF testing when requested.

Generally, when a new formula is created by the lab team, it will go through a rigorous set of tests. The set of tests include stability, preservative efficacy, and a challenge test. Stability tests ensure the formula does not change over time when resting at room temperature, or in variable temperatures so we test at room temperature (25 degrees C), accelerated temperature (45 degrees C), and also conduct freeze/thaw cycles.

Stability testing is done for 16 weeks total and is one of the tests that help ensure a two-year shelf life. During this time, the formula goes through the preservative efficacy test which tests for whether or not the formula is free of germs during the lab formulation process.

Lastly, the challenge test is done by our in-house Microbiology team and will test the germ-fighting power of the formula by inoculating the formula with a multitude of germs and observing the results on a logarithmic scale. This test is usually conducted after the formula passes the 4 week stability time, and is done in parallel. This is not the full set of tests a formula requires and other tests include packaging compatibility testing which RNA does not conduct, and topical tests such as HRIPT which RNA helps manage through a third party vendor.

WERCS

Our team is well aware of the requirements of getting your brand and product range onto the WERCS platform. Not only do we work with Underwriters Labs (UL) for product testing, but we also are experts with the WERCS requirements. One submission will allow your product to be easily adopted by all major US retailers including Walmart, Target, Walgreens, CVS, and more.

Claims Validation

We handle all third-party testing of products to ensure regulatory compliance. This allows our partners to focus on other facets of their business instead.  Our goal as a contract manufacturer is to help our brands avoid as much hassle as possible. That's why we arrange all third-party testing, such as HRIPT and SPF, ourselves. We also have in-house Analytical, Microbiological, and Quality Control testing labs as well to help along the way. We are committed to quality and excellence, and welcome third-party test results to help confirm these values, as well as provide our partners with peace of mind.