Residual Efficacy Testing : New EPA testing available

The Covid-19 pandemic changed many of the ways we understood public and personal safety, particularly the concept of antimicrobial efficacy. In response, the EPA has begun clarifying and establishing these pathways to simplify the testing, registration, and marketing of antimicrobial products. In October of 2022, the EPA issued guidance on adding residual efficacy claims to antimicrobial products. Click below to learn more or reach out to our expert team to schedule your study today.

Monkeypox Virus Efficacy Testing - Scheduling Now Available

on June 29^th, 2022, the USDA approved the importation permit for our facility to receive the Monkeypox Virus for testing in our Biosafety Level 3 lab (BSL-3). As a result, we are now scheduling product efficacy testing against the Monkeypox virus, with testing to begin late July.

We are also scheduling Biosafety Level 2 (BSL-2) surrogate testing in accordance with the EPA’s list Q strain requirements. It is important to note that if you wish to claim Monkeypox Virus efficacy on your products label, you must test against that specific strain. Surrogate evaluations will not suffice.

We will be scheduling testing on a first-come first-served basis for all testing. If you are interested in a Monkeypox virus efficacy test, please reach out to our expert team by clicking below.

BioScience Laboratories (Nelson Labs Bozeman), a Nelson Labs Company, Gains CDC Approval

BioScience Laboratories, a Nelson Labs company located in Bozeman, MT, and a leader in topical antimicrobial-product testing in the consumer, pharmaceutical, and medical-device industries, operates a biosafety-level-3 (BSL-3) laboratory that was inspected by the US Centers for Disease Control and Prevention (CDC) on 22 September 2021. The CDC has since confirmed that the Bozeman facility’s BSL-3 lab and related procedures adequately meet CDC guidelines for BioScience Laboratories to test all common and concerning strains of SARS-CoV-2 and other potentially dangerous pathogens.

FDA Deferment On Alcohol Based Handrub Products To End Dec. 31

On October 12, 2021 the FDA’s Center for Drug Evaluation and Research (CDER) released a notification that it intends to withdraw the three guidance documents regarding temporary policies for production / preparation of Alcohol Based Handrub Products due to the observation that supply of hand sanitizers by traditional drug manufacturers now meets demand. The FDA has stated that these guidance documents are intended to be withdrawn on December 31, 2021. Manufacturers that entered the hand sanitizer market during the pandemic, and took advantage of deferred testing requirements, must meet the FDA regulatory guidelines if they wish to continue sales of these products past the deadline.

BioScience Laboratories (Now Nelson Labs Bozeman) hosts a team of experts with years of clinical testing experience for personal and healthcare antiseptic products. Talk to one of our experts today to get your clinical efficacy study underway.

SARS-COV-2 - Topical Disinfectant Efficacy Testing

Looking to add claims against Covid-19 to your marketing or product label? We can help you get the necessary data for product registration and additional marketing and label claims. Our Biosafety Level - 3 laboratory allows us to offer efficacy testing directly against SARS-COV-2. Speak to one of our experts today.

Clinical Studies - Coronavirus Efficacy Testing

Our dedicated laboratory and recruitment teams are ready get you the clinical testing data you need on the timeline you want.

Custom Study Design - Get The Exact Data You Need

Our experts are on stand by to discuss the design of your next study. Both standardized and custom protocol development available.