Expert Consulting Services
Strategic Drug Safety & Regulatory Leadership
SagePharmaSolutions Ltd provides high-level pharmaceutical physician expertise across all phases of the product lifecycle from first-in-human clinical trials to post-marketing, out-licensing, and sunsetting.
Led by Dr Anne-Ruth van Troostenburg de Bruyn, we help biopharmaceutical companies build compliant PV systems, secure regulatory approvals, and mitigate asset risk.
Core Focus Areas
With over 20 years of experience
in the pharmaceutical industry in Pharmacovigilance,
Drug Safety, Pharmacology, Medical Affairs, and Clinical Development.
Pharmacovigilance & QPPV
Full PV system build, PSMF development, inspection readiness, and Qualified Person for Pharmacovigilance (QPPV) services.
Regulatory Dossiers & Submissions
Specialist drafting of CTD dossiers (Modules 2.5 and 2.7.4), Risk Management Plans (RMP), and Signal Detection for EU MAA and US NDA.
Due Diligence & Clinical Strategy
Expert asset evaluation for M&A, system integration post-deal closure, and medical monitoring for clinical trials and PASS.