Blackbriar Regulatory Services (BRS), a firm specializing in helping small-sized to mid-sized companies bring regulated products to market, is expanding.
Expansion efforts include adding cleanroom manufacturing space, increasing 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 in a statement.
“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 is under contract to file more product 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 vapor products for companies that are seeking to revitalize their product portfolio after the recent industry-wide focus on obtaining approval for legacy products.