Signal Pharma Experts Ltd

Signal Pharma Experts Limited is a drug safety consultancy that helps biotech innovators navigate pharmacovigilance (PV) regulations. The company describes its purpose as helping biotech companies overcome drug safety challenges, simplifying the complex process of globalising PV, and ensuring therapies reach patients while meeting regulatory standards. It partners with biotech companies from clinical trials into post-marketing, providing drug safety advice built on industry experience.

The company serves clients ranging from small and emerging biotechs to large global pharma groups, with a speciality in late-stage biotech preparing to launch products in the European Union, US, Canada and the UK. Services include gap analysis, process development, pharmacovigilance vendor selection and management, clinical safety strategies, scientific writing, mergers and acquisitions support, fractional head of drug safety roles, QPPV provision, and quality and audits. The team has led over 10 regulatory inspections, over 150 drug safety audits, and authored over 2,000 reports, with over 100 years of regulatory pharmacovigilance experience.