About Us

SagePharmaSolutions Ltd provides senior-level pharmaceutical physician leadership and consulting services to biopharmaceutical companies, biotechs, and regulatory stakeholders worldwide.

Founded by Dr Anne-Ruth van Troostenburg de Bruyn, the practice bridges deep clinical expertise with executive regulatory oversight. Having served as Vice President and EU QPPV for global pharmaceutical leaders—including Gilead Sciences and Takeda Development Centre Europe—Dr Anne-Ruth brings rare, high-level perspective to drug safety architecture, complex regulatory submissions, and high-stakes corporate due diligence.

Dr Anne-Ruth is a Senior Pharmaceutical Physician with over two decades of international experience spanning Pharmacovigilance, Drug Safety, Pharmacology, Medical Affairs, and Clinical Development.

Her broad technical background covers all stages of the asset lifecycle—from first-in-human clinical trials and lifecycle management to post-marketing safety, outlicensing, and asset sunsetting.

Core Expertise Areas:

• Global Regulatory Submissions: Directing licensing applications across EU MAA, US NDA, and global jurisdictions. Expert authoring and review of CTD Safety modules, including Clinical Overviews (Module 2.5), Summaries of Clinical Safety (Module 2.7.4), Efficacy, and Pharmacology.
• QPPV & PV System Build: Full-scope Qualified Person for Pharmacovigilance (QPPV) representation, Pharmacovigilance System Master File (PSMF) creation, process development, and audit/inspection readiness.
• Risk Management & Signal Detection: Designing Risk Management Plans (RMP), risk minimisation strategies, Post-Authorisation Safety Studies (PASS), and advanced signal detection frameworks.
• M&A Due Diligence & Integration: Technical and medical evaluation of assets and PV systems for major corporate acquisitions, in-licensing deals, and post-merger integration.