Market Access, HTA & Regulatory Strategy for Pharma and Biotech in Italy and Europe

Oliba Healthcare and Pharma is a Rome-based science and strategy advisory firm. We support pharmaceutical and biotech companies, start-ups and investors in bringing innovative therapies to patients. We combine scientific depth with first-hand knowledge of how regulators and payers assess value.

What we offer

• Market access and pricing & reimbursement: access strategy, value dossiers, payer negotiation support and managed entry agreements

• Health Technology Assessment: evidence strategy, cost-effectiveness and budget impact analysis, and preparation for the EU HTA Regulation

• Regulatory strategy: development and lifecycle planning, including advanced therapies, drug repurposing and digital health

• Scientific due diligence: asset and portfolio assessment for business development, licensing, investment and M&A

• Stakeholder engagement: multi-stakeholder programs with KOLs, clinicians, patient associations and institutions

Why Oliba
Our founder, Alessandro Monaco, spent seven years at the Italian Medicines Agency (AIFA) working on pricing, reimbursement and HTA. He also served as Assistant Director for Molecular Genetics at the US National Institutes of Health, holds an HEC Paris Executive MBA and teaches at LUISS Business School. Our multidisciplinary team of 10+ professionals works with top-tier international pharma clients and has coordinated EU-funded consortia across Europe.

Who we work with

• Pharma companies launching or expanding products in Italy and Europe

• Biotech start-ups and university spin-offs preparing for development, partnering or fundraising

• Investors, VC funds and law firms needing independent scientific and regulatory assessment

How we work
Engagements range from focused projects, such as a pricing strategy or due diligence report, to ongoing strategic advisory. Every engagement comes with a clear scope, timeline and budget.

Contact us to discuss how we can help your therapy reach patients faster.