RICHMOND, Va., Aug. 18, 2020 (GLOBE NEWSWIRE) -- via NetworkWire – Blackbriar Regulatory Services (BRS), a firm specializing in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market, announced today that it is expanding its facility and services to meet growing client demand. Immediate expansion efforts include increasing cleanroom manufacturing space, increasing its analytical capabilities, and expanding regulatory service offerings.
BRS was established specifically to address challenges such as those that the PMTA (Premarket Tobacco Product Application) process creates for manufacturers and brand holders, and its unique business model and capabilities provide numerous cost and speed advantages to clients who are looking for solutions to keep their products on the market in the United States. BRS is under contract to file more applications before the Sept. 9, 2020, deadline for several U.S. and international customers, and is now starting to prepare PMTA submissions for next generation nicotine-based vaping products for companies that are seeking to revitalize their product portfolio after the recent industry-wide focus on obtaining approval for legacy products.
BRS has spent a significant amount of resources building its regulatory team, certified class 6 cleanroom, ISO 17205 analytical lab, and manufacturing capabilities preparing for the regulatory pathway to meet the FDA’s public health expectations.
“With the FDA PMTA deadline approaching within weeks for existing nicotine-based vaping products currently on the market, we are now seeing an increase in PMTA demand for new, innovative nicotine-based vaping products,” said Russ Rogers, CEO at BRS. “The FDA rightly worked with the industry to pause and take a look at the appropriateness of the products on the market, and those companies who understand how to make the highest-quality products are in a position to start working on applications for next generation technologies that should create dramatically improved user experiences and step-wise safety improvements. It’s a very exciting time for adult smokers looking for tobacco alternatives that they can trust, and we are excited to be partnering with companies to help them to build compliance into new products that they have in their pipelines right from the concept stage.”
Post Market Surveillance is an integral and mandatory commitment manufacturers must make to the FDA as part of their PMTA submission. BRS has also expanded its capabilities in this area to service clients both domestic and international to help them remain compliant in this regard.
All FDA compliant e-liquid and device manufacturers have until Sept. 9, 2020, to submit PMTAs under section 910 of the Federal Food, Drug, and Cosmetic Act. As the FDA reviews the applications, compliant products can remain on the market during the review process. If the PMTA provides sufficient scientific data to demonstrate that marketing the new tobacco product is appropriate for the protection of public health, the FDA will issue a marketing order, which means the product can continue to be sold to consumers.
About Blackbriar Regulatory Services
Since its inception, BRS has perfected processes in cost efficient manufacturing, analytical testing, regulatory compliance audits and filings, rigorous project management, packaging design, and product stewardship for customers in the United States, Europe, and Asia. BRS prides itself on speed and flexibility, while never compromising quality or their customers’ confidential information. Learn more at www.bb-rs.com.
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