Pharma Consulting Shah

Right-sized development operations and RBQM advisory for biotech and growth-stage pharma.

Most emerging biotechs don't need a bigger operations function. They need the right one. Pharma Consulting Shah assesses where you are, prioritises what matters, fills the gaps, and implements a fit-for-purpose operating framework that equips your existing team rather than replacing it.

What I do

Clinical operations diagnostics and inspection-readiness assessment. A structured view of where your QMS and trial-delivery capabilities stand against where your pipeline needs them to be.Risk-based quality management (RBQM). Design and implementation of proportionate, ICH E6(R3)-aligned frameworks, from central monitoring strategy through to operational rollout.Operational scale-up for Phase 2/3 delivery. Building the systems, oversight, and vendor governance that a growing trial portfolio demands.Operational due diligence for investors. Independent assessment of portfolio-company clinical operations and readiness.

Background

Twenty-five years across clinical development leadership in large pharma, biotech and CRO settings, including Novartis, GSK, GE Healthcare. Co-founder of a clinical services group scaled to 250+ associates across 25 countries. Contributor to ICH E6(R3) and E8(R1). PhD, University of London. PMP; Lean Six Sigma.

Contact

Dr. Syed Shah
[email protected]
Basel, Switzerland and London, UK
+41 78 851 5568 and +44 7512 087256
https://www.linkedin.com/in/syedaashah/