Life Sciences, Pharma & Healthcare Solicitors in Ireland
Holmes delivers end-to-end legal support, from regulation and trials to commercial/IP, market access, manufacturing/quality, digital health/data protection, and disputes.
We advise life sciences, pharma and healthcare organisations across Ireland with clear, practical legal support from R&D through to market access.
How We Support Life Sciences & Pharma Sectors
- Regulatory approvals and compliance (Health Products Regulatory Authority and EU frameworks)
- Clinical trials and research agreements (sponsors, sites, CROs, ethics)
- Commercial and IP (licensing, collaboration, manufacturing, distribution)
- Market access, pricing, reimbursement and procurement routes
- Manufacturing, quality and supply (Good manufacturing and distribution practices, recalls, continuity)
- Disputes and investigations (product liability, enforcement, reputation)
Life Sciences & Pharma Regulation
Classification, authorisation and ongoing compliance for medicines, medical devices and diagnostics under Irish and EU rules. We advise on HPRA engagement, vigilance and safety reporting, advertising and labelling, and post-market obligations.
Clinical Trials & Research
Pragmatic support for sponsors, sites and research offices: clinical trial and site agreements, CRO arrangements, consent and data use, ethics approval and cross-border collaborations to protect participants, timelines and IP.
Commercial & IP
Licenses and collaborations, manufacturing and supply, distribution and co-marketing, technology transfer and spin-outs, confidentiality and material transfer agreements structured to protect assets and move quickly.
Market Access & Procurement
Pricing and reimbursement strategy, tendering and procurement compliance, managed access and outcomes-based arrangements, and payer contracting to facilitate innovative products reaching patients with commercial certainty.
Manufacturing, Quality & Supply
GMP/GDP compliance, quality and technical agreements, audits, recalls and field safety actions, and risk allocation across complex supply chains to safeguard continuity.
Digital Health, Data & Privacy
Medical software and connected devices, telehealth pathways, clinical and research data governance, Freedom of Information (FOI) where relevant, and GDPR-compliant policies across trials, registries and real-world evidence.
Disputes & Investigations
Early risk assessment, product liability defence, regulatory inspections and enforcement, urgent relief where needed, and crisis/media strategy focused on protecting patients, reputation and value.
Healthcare Providers & Hospitals
End-to-end support for public, private and not-for-profit providers: clinical governance and risk, accreditation and regulatory compliance, corporate structuring and strategy, professional discipline and medico-legal issues, employment and workforce matters, data protection and patient privacy, real estate and development, and technology procurement/digital health agreements. We also support management teams with crisis response and the defence of employers’ liability, public liability, product liability, and medical malpractice claims.
Integrated Support Across Trials, Commercialisation & Operations
These are the three capabilities we most often combine with regulatory advice, so that your programs stay compliant, defensible and deal-ready.
Data Protection & Privacy
Design lawful clinical and research data use, complete impact assessments, and handle Freedom of Information and data-subject access requests without slowing studies.
Dispute Resolution
Contain risk fast, manage product-liability and regulatory disputes, secure urgent court orders where required, and resolve claims with minimal disruption.
Corporate / M&A
Structure investments, partnerships and acquisitions to protect IP, align incentives and accelerate market access and growth.
Contact Us
Need practical, sector-specific advice? Speak to our Life Sciences & Pharma team for a confidential consultation.
