Comparator-Drug Sourcing Strategy for
Global Clinical Trials

A boutique consulting firm helping pharma sponsors design and execute end-to-end strategies for comparator drug procurement.

What We Do (Core Services)

Our mission is to enable sponsors to run trials on time and on budget by de-risking comparator supply—without compromising ethics, patient safety, or data integrity.

Strategy & Road-Mapping

Molecule/arm mapping, originator vs biosimilar strategy, global vs local sourcing mix.

Regulatory & Quality Pathfinding

Navigating EU GDP/GMP, QP release, US DSCSA, EU FMD, import/export, and more.

Supplier & Market Intelligence

Screening manufacturers and wholesalers across key global markets.

Cost/Risk Optimization

Total landed cost models, expiry/overage planning, and logistics design.

Operational Tooling

Forecasting, demand models, RFP/RFQ packs, bid leveling, and contract playbooks.

Issue Response (“SWAT”)

Rapid root cause and recovery plans for shortages, recalls, or protocol changes.

How We Work

Our structured, data-driven process ensures transparency and optimal outcomes for every engagement.

Assess

Protocol(s) & timelines review

Model

Scenario modeling (cost/lead-time/risk)

Select

Optimal route selection

Enable

Supplier, QA, and lane setup

Monitor

KPIs and escalation path monitoring

Global Reach, Local Expertise

We tailor sourcing strategies to the unique regulatory and logistical landscapes of key regions worldwide.

North America

DSCSA compliance, large-scale distribution, and direct-to-site logistics.

European Union

GDP/GMP standards, QP release management, and navigating FMD requirements.

Asia-Pacific

Complex import/export regulations, diverse market access, and cold-chain integrity.

Emerging Markets

Navigating regulatory uncertainty, establishing secure supply chains, and risk mitigation.

Why Sponsors Choose Us

Our unique combination of focus, expertise, and data-driven methodology sets us apart, delivering unparalleled value to your clinical programs.

Comparator-Only Focus

Specialist depth across originators, biosimilars, and generics.

Regulatory Fluency

Expertise across EU, USA, Japan, China, South Korea, and GCC.

Networked Access

Relationships with MAHs, manufacturers, and licensed wholesalers.

Typical Deliverables

We provide clear, actionable documentation to guide your strategy and execution from start to finish.

Comparator Strategy Dossier

Global Supplier Shortlist

RFP/RFQ Package & Bid-Leveling Report

Regulatory Route Map

Execution Playbook

Meet Our Founder

KEG Pharma was founded by Dr. Khaled El-Gendy , an industry veteran with over 25 years of experience across clinical-trial supply, regulatory affairs, and licensed wholesale operations. Our founder’s expertise includes Japan/EU/US import-export, QMS design, and high-stakes shortage mitigation. We adhere to GxP, anti-bribery/anti-corruption standards, and maintain audit-ready traceability from MAH/manufacturer/wholesaler to clinical site—protecting patients and preserving data integrity.

Ready to Optimize Your Next Trial?

Contact us today for a confidential consultation. Click our email below or fill out the form to get started.