"Bringing a Schedule 1 product like psilocybin into human trials is a regulatory minefield. Broughton helped us design and execute a clear CMC strategy from analytical method development to stability and batch testing under GMP. Their integrated support made our IMPD submission much smoother and gave the MHRA confidence in our data package. They were more than a service provider, they were part of our core development team."

Chief Scientific Officer, UK-Based Biotech Company

"We needed GMP-compliant testing for our formulation, and Broughton’s Schedule 1 licence, validated methods, and seamless onboarding made this complex process feel very smooth indeed. Their scientific and regulatory team understood what was needed for our CTA and delivered on time. This is a partner that truly understands the pressure of early-stage development and helped us project manage tough deadlines.”

Director of Regulatory, European Pharmaceutical Manufacturer

“Preparing our IMPD for a novel psychedelic-assisted therapy was a major milestone and Broughton’s support was invaluable. Their team led the analytical method development, ICH-compliant stability studies and CMC documents, while guiding us on toxicology strategy and linking with GLP labs. Their scientific clarity, GMP documentation standards, and responsiveness helped us submit a complete and defensible dossier to MHRA on time. This is the kind of partner you want when time and quality matter."

VP Regulatory Affairs, US-based Biotech Company