Pharmacovigilance & Safety Monitoring
End-to-end case management, ICSR reporting, signal detection, risk management plans (RMPs), and aggregate reports.
View Pharmacovigilance Services →Technical Precision.
Patient Safety.
Founder-led Pharmacovigilance and Regulatory Affairs support for global biotech and pharma.
Core Practice Areas & Technical Services
Regulatory Affairs & Market Authorization
Expert UK and EU regulatory strategy, CTA & MAA authoring, variations, and compliance lifecycle management.
View Regulatory Affairs →Medical Support & Clinical Safety
Clinical safety oversight, expert medical review, benefit-risk assessments, and clinical trial safety management.
View Medical Support →Directorship & UK Inspection Success
Hands-on Technical Leadership
Led by founding directors Lisa Hughes and Jackie Roberts, providing senior-level technical advisory, ex-MHRA inspection readiness, and post-Brexit UK QPPV representation.
Authoritative Regulatory Guidance
We operate in strict alignment with major UK and EU health regulatory agencies: