By Timothy S. Donahue

Top Takeaways:

• Regulatory milestone: Broughton achieved GMP accreditation at its Oak Tree House facility after an MHRA inspection.
• Testing expansion: The site now supports high-resolution mass spectrometry and controlled drug testing.
• Client focus: The company emphasizes dedicated teams and regulatory-ready data as demand increases.

Contract research organization Broughton is expanding its regulatory testing capabilities after obtaining Good Manufacturing Practice (GMP) accreditation for its Oak Tree House facility, reinforcing its role as a compliance partner for nicotine and pharmaceutical products.

The accreditation, granted following an inspection by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), builds on Broughton’s existing GMP-certified operations and broadens its ability to support clients navigating increasingly complex regulatory requirements.

“Achievements like achieving GMP accreditation are only possible when there is collective ownership of quality and a commitment to doing things the right way across the business,” said Chris Allen, CEO of Broughton.

With the certification, the Oak Tree House site now has GMP accreditation, ISO 17025 accreditation, and controlled substances licenses up to and including Schedule I, enabling it to perform highly regulated testing across various product categories, including next-generation nicotine products.

Broughton said the expansion will enable it to provide higher capacity and advanced analytical abilities, such as high-resolution chromatographic mass spectrometry.

“Following the certification, we can now offer expanded GMP capability… alongside increased capacity to support future growth,” Allen said.

The company is also adopting a client-specific operating model, assigning dedicated teams aligned with individual customer portfolios to enhance technical expertise and accelerate turnaround times.

“By combining small, client-focused teams with strong cross-functional collaboration… we deliver a level of GMP service that goes far beyond data generation,” Allen said. “We provide genuine confidence and reassurance that processes are delivered to the highest standards.”

The move comes as regulatory scrutiny continues to rise across the nicotine industry, especially for products that require premarket tobacco product applications (PMTAs) and other compliance pathways in the U.S. and worldwide.