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, is expanding.
The company announced today that it is growing its facility and services to meet increasing client demand. Immediate expansion efforts include adding cleanroom manufacturing space, increasing its analytical capabilities and expanding regulatory service offerings.
“With the [U.S. Food and Drug Administration’s (FDA) premarket tobacco product application (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.”
BRS was established to address challenges such as those that the PMTA process creates for manufacturers and brand holders. 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, according to Rogers.
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.
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, according to Rogers.