Making life-science innovations approvable, accessible, and scalable across the EU and GCC through evidence-driven strategy and execution.
Our company
Onyx BioPartners supports life-sciences innovators across Europe and the GCC, from pharma and medtech to diagnostics, supplements, and digital health.
We structure evidence strategies, optimize development and regulatory routes, orchestrate market entry, and design adoption frameworks where scientific rigor meets commercial pragmatism.
Every decision backed by scientific, regulatory, and commercial rigor.
EMA, FDA and GCC regulatory pathways under one roof.
We build alongside you, from plan to approval to launch.
What we do
Six integrated practices. One strategic team. Engage us end-to-end or for any single stage of your journey.
From early pre-clinical development to evidence-backed supplement to R&D, we structure your development roadmap with clarity and precision.
We stage clinical programs that move efficiently from protocol to execution, integrating strategy, operations, and risk mitigation.
Approval is not paperwork. It is positioning. We develop complete evidence packages for EU, GCC, and global submissions.
Strong science must be communicated with authority. We support medical strategy, scientific messaging, and KOL engagement.
Innovation only succeeds when it is adopted. We define market access strategy, pricing, and reimbursement positioning.
Growth requires financial intelligence. We support capital readiness, financial structuring, and funding strategy alignment.
Fixed scope. Fixed timeline.
Defined deliverables on a defined schedule — engineered for teams that need answers before their next board meeting, partnering discussion, or filing decision.
A complete map of the regulatory pathways, classifications, and evidence requirements for your product across your target markets — the document investors and partners will ask for.
An honest assessment of whether your organization would survive pharma due diligence — data integrity, quality systems, IP hygiene, and regulatory positioning — with a prioritized fix roadmap.
Deep science translated into investor language. Deck copy, one-pager, and a data-room regulatory summary that make your program legible to non-specialist capital.
Targeted partner and KOL outreach, scientifically written and professionally managed. We identify the right 20–30 targets, open the doors, and run the follow-up.
A product-by-product launch-readiness verdict for a new market — regulatory risk, classification, claims compliance, and commercial viability across your full SKU list.
Your fractional quality function. We set up and run GLP/GxP frameworks, quality management systems, SOPs, and data integrity practices — sized for a growing company, not a multinational.
Most clients begin with a single fixed-scope engagement and expand from there. Tell us where you are, and we’ll recommend the right entry point — no obligation, proposal within two business days.
Our clients
We support life sciences companies preparing for approval, launch, market entry, and strategic expansion.
Let's talk
Book a call or send us a note. We respond to every inquiry within two business days.
Free guide · 2026 edition
Which pathway your product actually falls under, the documentation that decides whether a filing moves or stalls, and where entry plans usually go wrong. Choose your market — or take both.
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