Legal representation is a fundamental regulatory requirement for foreign (ex-EU) companies operating in the EU life sciences sector. 

Whether entering the EU market, conducting clinical research, or maintaining compliance in the EU, legal representation is essential. 

Merilane offers tailored EU Legal Representation solutions that support your success across every stage of the product lifecycle.

End-to-end Regulatory Solutions as your Regulatory Business Partner. 

Merilane provides strategic and operational regulatory support across the full product lifecycle, from early development to post-market compliance. 

Our services include global regulatory strategy, dossier preparation, agency engagement, lifecycle management, and support with evolving frameworks. 

Whether you're seeking market entry or maintaining compliance, Merilane helps you navigate complexity, mitigate risk, and accelerate approvals.

Stay ahead of evolving regulations, emerging trends, and competitor activity with our tailored Healthcare Intelligence solutions, provided by our Healthcare Intelligence newsagent, The Abbey Newsagents Ireland.

It's dedicated healthcare intelligence department, AbbeyNews - Healthline, provides proactive, strategic insights to support regulatory planning, product development, and market entry.

Our services include:

Monitoring and interpretation of global regulatory developments (EMA, FDA, MHRA, NMPA, and more)

Impact assessments of new guidelines, policy shifts, and legislation

Competitive intelligence on product pipelines, approvals, and submission strategies

Country-level regulatory pathway analysis and risk mitigation planning

Custom reports and alerts aligned to your therapeutic area and product lifecycle stage.

By combining expert analysis with real-time data, we help you navigate complexity, reduce uncertainty, and make informed decisions—whether you're entering a new market, preparing a submission, or planning post-approval strategies.

Merilane delivers expert QA and Quality Management System (QMS) support to ensure your operations meet global GxP standards across the product lifecycle. 

Our services cover QMS design, Quality plans (1-3 year), Audit readiness, Deviation and CAPA management,  Inspection preparation support, and more. 

Whether you need to build a QMS from scratch or strengthen existing processes, Merilane helps you embed Quality into the DNA of your organisation, ensure regulatory compliance, and drive continuous improvement across departments and third parties.

Merilane provides independent, risk-based GxP auditing services across the full spectrum of regulated activities, including GCP, GMP, GLP, GDP, and GVP. 

Our experienced auditors conduct vendor audits, internal audits, mock inspections, and gap assessments to help you identify compliance risks and implement effective corrective actions. 

Merilane Audit & Compliance Solutions will put your QMS to the test to help ensure it is robust and inspection-ready.

Merilane scientific and medical writing expertise translates complex data into clear, accurate, and regulatory-compliant documentation per industry best practices including GPP3. 

Our solutions span clinical study protocols, investigator brochures, regulatory submissions (e.g., CTD modules), study reports, technical QA documentation as well as publication-ready manuscripts and blogs. 

Our strategic input and hands-on writing support helps ensure your data is presented with clarity, consistency, and scientific integrity while tailored to regulatory and stakeholder expectations.

We provide specialised project and program management support across the product development lifecycle. 

Our consultants bring structure, clarity, and momentum to complex initiatives—ensuring alignment across cross-functional teams, managing timelines, budgets, and risks, and driving delivery against strategic objectives. 

From leading a single project to coordinating global clinical development programs, Merilane is well-positioned to help you stay on track, on time, within budget and inspection-ready.

Are you maximising your scientific staff resources? 

Merilane helps you increase efficiency, effectiveness and motivation of your teams through data-driven staff utilisation analysis and optimisation. 

By assessing, for example, workload distribution, role clarity, and resource alignment, we identify and resolve gaps, painpoints, duplication, unnecessary tasks as well as underused capacity. 

Our tailored recommendations improve productivity, reduce burnout, and ensure your teams are motivated and focused on high-value, compliance-critical activities—supporting sustainable growth and operational resilience.

中国的药物开发要求与欧盟存在显著差异。Merilane 可协助中国企业有效应对欧盟复杂的监管框架，助力顺利达成合规与获批目标

Merilane's 'Access EU' programme makes it easier than ever for companies based outside the EU to access the EU market. 

Click below or contact us today for more details.