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.
on June 29th, 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, 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.
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 The FDA has stated that these guidance documents are intended to be withdrawn on December 31, 2021.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.
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.
Read our full press release regarding the launch of our new Biosafety Level - 3 Laboratory. This new lab will allow for testing to be extended to new agents such as SARS-COV-2.Read Now
Read our full statement as our home state of Montana navigates through phase 2 of the reopening procedures. Careful precautions while still offering all our regular services.Read Now
Our Senior Scientist ,Christopher M. Beausoleil, B.S., CCRP, examines the possible effects on skin and the consideration of compatibility between products. Read his full article below.Read Now
How is your product superior? We can provide you with the data to differentiate your product in today’s competitive market. Working as a team, our staff can custom-design stud...View Service
In order to quickly and efficiently validate your products, Nelson Labs Bozeman offers both Clinical and In-vitro industry standard testing. Our methods (ASTM, EN, AOAC, ISO) ...View Service
The Skin Technology Center offers a broad spectrum of clinical and in vitro safety testing services. In clinical safety testing, NLB evaluates in-use safety of products by mea...View Service
BioScience Laboratories can help you formulate how best to achieve your results based on our expertise and quantitative analysis decision-making, considering cost-benefit and ...View Service
Nelson Labs Bozeman has over 30 years of experience performing standard (AOAC and EN) disinfectant testing methods, including custom-designed efficacy tests for EPA registrati...View Service
BioScience Laboratories has twenty three years of experience in conducting clinical & in-vitro studies on antimicrobial products used in food service, healthcare, and jani...View Service
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The BioScience Laboratories Skin Technology Center offers clinical testing services for both personal and professional skin care products. Standard, validated protocols have b...View Service
We believe the accurate interpretation of study results is critically important to a study's value. Hence, the results from studies that include a statistical design are more ...View Service
BioScience Laboratories, Inc. has worked with wound dressings for more than 20 years. We offer a way to sell your products for more bottom-line profit to you. We evaluate seve...View Service
Real Time PCROur experts here at BioScience Laboratories demonstrate in depth knowledge utilizing a variety of PCR methods and equipment to get you the data you need in the ti...View Service