Accelerated Registration
Challenge
When Saudi Arabia introduced new priority-review pathways, a company needed to know which products could qualify and how to use the route to speed market entry.
approach
Screened the portfolio against the new criteria, built the strategy and dossiers, and managed SFDA submissions to win approvals in months, not the standard timeline.
Regulatory strategy
Challenge
A product was US FDA-approved but awaiting EMA sign-off; with commercial supply from Europe, waiting would have delayed local launch.
approach
Filed the local dossier on the strength of the US approval and ran registration in parallel with the EU process, completing the remaining requirements once EMA approval landed saving months to market.
Lifecycle portfolio operations
Challenge
A major global portfolio integration required regulatory transfer of a very large product range across multiple markets, without disrupting supply or compliance.
approach
Led the multi-country regulatory workstream, including licence transfers, variations and artwork changes across 3,000+ transfers and 30+ launches.
licence remediation & compliance
Challenge
A multinational's UAE portfolio of ~54 SKUs carried pending renewals and lifecycle changes just as the authority began holding shipments for products with outdated licences.
approach
Built a structured remediation plan with renewals, licence and manufacturing-site transfers, packaging and variations run in parallel and negotiated shipment releases directly with the health authority to keep supply flowing.
Access insights, strategy and planning
Challenge
A biotech bringing a high-cost advanced therapy (ATMP) to the GCC, where no funding route, pricing precedent, or reimbursement pathway was established for an entirely new treatment category.
approach
Conducted a market-access and approval-stage assessment across the markets, built a comprehensive payer–regulator–institution stakeholder map, and developed a prioritised, sequenced engagement and funding-pathway plan.
Pricing, access insights & planning
Challenge
A biotech launching the first approved oral therapy for a rare disease with no prior standard of care, and no local pricing or reimbursement precedent to build on.
approach
Payer value proposition, pricing and access-pathway mapping, and targeted stakeholder engagement planning to establish reimbursement in the absence of precedent.
market insights & access strategy
Challenge
A global pharma needed on-the-ground insight into how neurologists, pharmacists and payers viewed a competitive therapy, to guide access expansion.
approach
Primary research with neurologists, pharmacists, and ex-payers to inform actionable access, pricing, and advocacy recommendations.
Health technology assessment (HTA)
Challenge
Specialty oncology medicine pursuing SFDA approval on the strength of a single-arm study, with health-economic models built for other jurisdictions and a strong competitor anticipated.
approach
Synthesised external-comparator evidence (historical and synthetic) to establish comparative efficacy for Saudi patients, built it into a partitioned-survival CEA model, and communicated it in plain language.
Advisory board
Challenge
A global pharma needed regional specialists aligned on where a new respiratory therapy fits, with the local case for use not yet established.
approach
Convened and chaired an expert advisory board, built around patient data that demonstrated the unmet need and the patients most likely to benefit.
Real world evidence studies
Challenge
Global trial data did not fully reflect regional patients and practice in this disease; local real-world evidence was needed to build prescriber and payer confidence.
approach
Designed and delivered a real-world evidence study capturing regional patient characteristics, treatment patterns and outcomes.
Medical education
Challenge
Oncology teams needed hands-on experience in identifying eligible patients and using a new oncology therapy, including biomarker-led selection.
approach
Ran a structured preceptorship programme at centres of excellence, covering biomarker-led patient selection and treatment management.
Delphi consensus
Challenge
Regional care in this autoimmune disease lacked population-specific guidance, delaying the right treatment and better outcomes.
approach
Ran a Delphi consensus with regional and international experts and supported the resulting peer-reviewed publication on earlier treatment.
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Practical thinking on registration, HTA, pricing and clinical adoption across the GCC, plus details of upcoming Veridian events.
Medical affairs & scientific communications
Medical affairs
Medical affairs & clinical research
Medical affairs
Market access & stakeholder engagement
Rwe, heor & business intelligence
Heor & market access
Regulatory affairs & market access
Director, Medical Affairs
Managing Director, HTA/HEOR and Market Access