What we do
LDMH Partners is a specialist advisory firm focused on health and life sciences. Our sector focus is narrow by design, reflecting the reality of a field where legal questions rarely stand alone and where regulation, ethics, policy and scientific practice are tightly intertwined.
We work cross‑border with organisations operating in clinical, research and commercial settings, supporting work from early research through to clinical application and real‑world delivery. Our advice addresses the legal, regulatory and governance issues that arise as science and technology move into practice, often under close scrutiny and with significant consequences.
What distinguishes our approach is not breadth, but depth. We understand the pace, pressures and purpose that shape this sector, and we tailor our advice to context - recognising that the challenges facing a start‑up, a research institution or an established organisation are rarely the same.
Sectors
Reproductive & Fertility Law
Genomic & Cellular Innovation
Health Data, AI & Digital Technologies
Medical Devices & Pharma
Clinical Trials
Health Regulation, Public Bodies & Policy
Women's Health, Wellbeing & FemTech
Our Sectors
Reproductive & Fertility Law
We are recognised leaders in this highly specialised field, advising clinics, fertility providers, and professionals across the assisted reproduction sector. Our expertise spans fertility preservation, legal parenthood, surrogacy, donor arrangements, encompassing diverse family structures and with it, the evolving frameworks of modern family law.
We also advise on wider reproductive healthcare services,including abortion, maternal health, and sexual and reproductive health, particularly where clinical practiceintersects with regulation. We support HFEA and CQC-regulated providers, drawing on our extensive experience in healthcare governance.
We are committed to supporting those who deliver reproductive care in all its forms, bringing legal precision and principled judgment to a field where stakes are professional, personal and political.
Our team have been involved in many of the most high-profile fertility cases in the UK.
We have advised numerous clinics and patients on the implications of the storage of their embryos and gametes, and the post-mortem use of the material.
We are leading experts in assisting clinics and patients in regularising consent in circumstances where there have been regulatory issues.
Genomic & Cellular Innovation
From gene therapies to cell-based treatments, this is a sector where the science moves faster than the rulebook. We advise clients working at the frontier of genomic and cellular innovation, where legal clarity is essential to navigate evolving standards, manage risk, as well as to build public and regulatory trust.
Advising across the full spectrum of genomic and cellular work, from early-stage research to clinical application, our strengths lie in reproductive and genetic technologies, genetic testing, and genomics. We work with universities, researchers, and spinouts across the innovation pipeline, supporting progress from lab to clinic to market.
We help turn scientific breakthroughs into regulated, real-world solutions, ensuring the legal foundations are in place for safe, ethical, and impactful innovation.
We have helped clients navigate the translational pathway from innovative cell-based product to ATMP.
We are leading experts in regulatory, legal, and ethical issues in biobanking and have assisted and advised biobanks in the UK and the EU.
We have provided training to research and clinic staff on the legal and ethical aspects of working with human tissues and biomaterials.
Related insights and cases
Health Data, AI & Digital Technologies
At the heart of modern healthcare innovation lies data – sensitive, high-value, and increasingly regulated. We advise clients working with electronic health records, medical informatics platforms, AI- and ML-powered tools, and other data-driven technologies.
We specialise in guiding clients to address the full spectrum of legal issues, from data protection, commercialisation, and cross-border transfers to algorithmic accountability and patient rights.
We collaborate with health tech companies, research institutions and digital platforms to ensure that innovation is not only compliant but also trusted and future-proof. By leveraging our knowledge, we help you unlock the potential of health data.
Our lawyers are involved in some of the leading research projects in AI and medicine.
We have advised a consortium developing an AI powered app for transplantation patients.
Our lawyers have advised on secondary data use of imaging data from population-based studies.
Related insights and cases
Medical Devices & Pharma
Bringing innovative medical devices, pharmaceutical products, and diagnostics to market is complex, and our expertise ensures you navigate the translational pathway successfully.
We assist clients developing and delivering cutting-edge medical devices and diagnostics, supporting progress from concept to commercialisation. From implantable devices to rapid diagnostic tests, we guide you through the legal and regulatory frameworks.
Our advice spans the full product lifecycle: clinical evaluation, UKCA and CE marking, MHRA engagement, and post-market surveillance. We also advise on product liability, data protection, advertising compliance, and commercial agreements, helping manage risk and unlock opportunity without slowing innovation.
We have advised clients on the conditions for marketing authorisation for their devices.
We have advised on to-market strategies for innovative tissue-engineered implants.
We have advised on regulatory issues surrounding the introduction of a cannabis-based device into the UK market.
Related insights and cases
Clinical Trials
Our team have been at the forefront of advising some of the most complex, ethically challenging, cross-border clinical trials. We fully understand that delay is one of the main issues affecting clinical trials, and we help our clients in ensuring that projects are kept on track, and on time.
From cross-border issues in international collaborative projects, over challenges of vulnerable research participant populations, to rare diseases research, we have been able to assist clients in performing successful clinical trials in the UK and Europe.
We help in drafting ethical frameworks, ensure compliant regulation, unlock secondary data uses, and ensure smooth transfer to data and materials across borders and institutions.
We have particular expertise in advising non-orthodox clinical trial consortia with particular methodological and epistemic challenges in evidence-generation, including in the context of implants, ATMP, and biologicals.
We advised a university hospital running a clinical trial on a rare disease on negotiating a consortium agreement with partners in six different jurisdictions.
We drafted material and data transfer agreements for a pan-European research consortium to ensure free flow of data and samples within a trial.
We advised a clinical trial consortium on compliance and ethics issues surrounding recruitment of vulnerable research participants.
Related insights and cases
Health Regulation, Public Bodies & Policy
In an ever-evolving landscape, we provide seasoned guidance on the legal frameworks that shape how health and care are delivered.
Our clients include providers, innovators, charities, and research bodies operating in complex regulatory environments. We advise on statutory powers, regulatory enforcement, and the legal risks that arise when public bodies make decisions that affect care, funding, or innovation. Our work often intersects with public law and individual rights, addressing critical issues of access, fairness, and accountability.
Whether you’re navigating regulatory challenges or striving to ensure fairness and accountability in health systems, our team is here to support you in making impactful changes.
We are a leading adviser on issues in relation to HFEA and HTA regulation.
We have been involved in some of the highest profile judicial reviews challenging public authority decisions in IVF and science.
We have provided policy advice to governments, public bodies, and advisory committees in the UK and Europe.
Related insights and cases
Women's Health, Wellbeing & FemTech
Women’s health and wellbeing is one of the most dynamic and fastest-growing sectors in the life sciences and consumer health. Longstanding gaps in research, regulation, and investment are finally being addressed – and a new generation of products, services, technologies, and evidence-based approaches is emerging.
In addition to reproductive and fertility technologies, we operate across the full spectrum of the women's health and wellbeing, as well as the FemTech space: from clinical research and regulated medical devices and diagnostics through to AI-powered tools, consumer health, intimate wellness, and lifestyle-focused programmes. We support FemTech startups and scale-ups, and digital health platforms through to established pharmaceutical and consumer health companies, research institutions, and policy bodies.
Whatever the concept or stage of development, we advise wherever law, regulation, and ethics intersect.
We advised on data protection and privacy compliance for a AI-powered health and wellness platform.
We support evidence generation and ethical compliance in women's health research.
We guide FemTech startups and scale-ups through the regulatory pathway.
Our Services
Commercial transactions
We’re your strategic partners in navigating the commercial landscape of the health and life sciences sectors. Our clients range from cutting-edge public research institutions to nimble start-ups and established biotech and pharma companies.
We draft, review, and negotiate commercial contracts that align with your goals, ensuring that your business transactions are both legally sound and strategically advantageous. Our expertise covers a wide array of commercial agreements, including licensing, collaboration, and supply and distribution contracts.
Leveraging knowledge and experience in the health and life sciences sectors, we craft bespoke solutions that drive growth and innovation while effectively managing risks.
Our Recent Experience:
Conducting due diligence for investments in and acquisitions of life science companies.
Drafting consortium agreements for multinational research collaborations.
Drafting and advising on material and data transfer agreements for biotech companies and academic institutions.
Regulatory Affairs
In health and life sciences, regulation isn’t a hurdle - it’s the scaffolding that holds up innovation. Because in this sector, success isn’t claimed, it’s constructed.
From clinical trials to AI-enabled diagnostics, from cannabis-based medicines to embryo research, we’ve advised on some of the most closely scrutinised areas of science and medicine. Our work spans the full regulatory lifecycle, including clinical trial approvals, ethics submissions, licensing, post-market obligations and recalls.
We don’t just know the rules, we understand why they exist, how they’re evolving, and how they apply in practice. We work with you to make sure your regulatory groundwork is solid.
Our Recent Experience:
Regulatory foresighting for decentralised clinical trials.
Drafting submissions for the authorisation of animal research.
Advising a global pharmaceutical company on regulatory issues relating to medicinal cannabis.
Advising a biotech start-up on marketing authorisation pathways fornovel tissue-engineered products.
Preparing ethics submissions for AI-enabled diagnostic technologies.
Representing clients before licensing committees in the biotechnology sector.
Advising on regulatory and licensing issues relating to IVF and embryo research in the UK and EU.
Compliance & Risk
Smart compliance starts early, is built to prevent, and is ready to respond. We work with you to assess the robustness of your existing compliance frameworks, develop risk-informed policies that hold up under pressure, and restore trust when it matters most.
Our team’s expertise in ethics gives us a distinctive perspective on the challenges that arise in complex research environments, particularly when regulatory scrutiny and reputational exposure is at play. We support clients in building forward-looking systems that reinforce both scientific integrity and commercial resilience, while also advising on urgent, high-stakes matters when scrutiny is already underway. This includes investigations into scientific or corporate integrity issues, strategic responses to reputational harm, and restoring trust in research and development processes.
Our Recent Experience:
Chairing a committee investigating allegations of scientific misconduct.
Advising a public research institution on the governance of ethically volatile research methods.
Advising a commercial R&D team in managing compliance and risk linked to self-experimentation.
Delivering training on responsible research practices and regulatory compliance in the context of clinical translation.
Providing tailored workshops on commercialisation and legal issuesrelating to human tissue and cell research.
Privacy & Data Protection
Privacy obligations in health and research settings are rarely straight forward, especially when data moves across borders, systems, and purposes. We advise clients on how to meet their data protection responsibilities with clarity and control.
Our work focuses on the practical implementation of data protection, from clinical care setting and health information systems to clinical trials, registries, AI tools and digital platforms. We advise on compliant data flows, the governance of secondary use, and international transfers, always with an eye to credibility and public trust.
We also support clients in drafting and negotiating data sharing agreements, conducting Data Protection Impact Assessments (DPIAs), data subject access requests and breaches.
Our Recent Experience:
Drafting and reviewing terms and conditions for a patient referral programme, including in relation to data protection compliance requirements.
Negotiating cross-border data transfer agreements for a health clinic in connection with screening services provided by an overseas laboratory.
Advising a start up in relation to secondary use of device data for commercial research purposes.
Drafting data protection provisions in stem cell storage agreements, including obligations related to third-party data processors and patient data handling.
Investigations & Inquiries
We advise and represent clients involved in inquiries, investigations, and committee proceedings. These may include public inquiries, licensing and ethics committees, fitness to practise panels, and internal investigations within healthcare or research organisations.
Our work includes drafting statements and submissions, coordinating with counsel where appropriate, and negotiating with regulators, panels, or opposing parties. We also provide strategic advice behind the scenes, helping clients manage reputational risk, respond proportionately, and maintain credibility under scrutiny.
We understand that these processes are often high-pressure. Our approach is discrete when needed, responsive, and tailored to the context.
Our Recent Experience:
Acting for two public bodies involved in the UK Covid-19 Inquiry.
Acting for a public body in a public inquiry into non-consensual human tissue retention.
Chairing an independent Inquiry into stem cell research governance.
Appointed as legal advisor to an independent inquiry examining thesuspension of a senior judicial figure.
Dispute Resolution
We’re in your corner when it matters most, acting as trustedadvocates in complex and sensitive disputes. Our role goes beyondlegal representation: we help clients resolve challenges withforesight and sound judgement.
Our experience spans disputesinvolving reproductive and genetic technologies, embryo research,genetic testing, and the use of emerging technologies in care andresearch. We’ve acted in many of the leading cases in these areasand regularly support clients in resolving matters that carry legal, reputational, and operational risk.
We provide advice across formallitigation, complaints, and other contentious matters. Whereappropriate, we engage with regulators, ethics bodies, and otherstakeholders to resolve issues through negotiation and strategicdialogue. Every dispute is approached with aclear understanding of the pressures, the principles, and the longview, helping you to protect your standing.
Our Recent Experience:
Acting in litigation concerning the posthumous use of gametes andembryos.
Representing private clinics in licence suspension proceedings.
Successfully defending a claim for breach of contract relating to theuse of stored embryos.
Representing a hospital in their successful court application forfirst-in-man compassionate use of a monoclonal antibody for thetreatment of an incurable disease.
Acting for a publicly listed company in connection with a regulatoryinvestigation and criminal prosecution by the UK Human TissueAuthority and the police.
Human Rights & Judicial Review
We help organisation hold public bodies to account. Our work spans human rights and judicial review in the context of health and life sciences, where legal frameworks often lag behind practice and innovation.
Our clients include companies, charities, research bodies and individuals seeking to challenge actions that are unlawful, unfair, or out of step with fundamental rights. Issues often involve access to treatment, the responsible use of emerging technologies or research governance.
Judicial reviews are time sensitive, and we move quickly when needed. We’re known for our ability to assess whether a decision is legally flawed, ethically questionable, or procedurally unsound. We’ve acted in a significant number of complex judicial review proceedings against a range of public authorities, and regularly advise on human rights compliance.
Lasting change doesn’t happen by accident – it happens through principled challenge. Our team works to ensure that the systems shaping care, research, and innovation are fair, lawful, and built to endure.
Our Recent Experience:
Successfully challenging a regulator's decision to impose licence conditions on IVF clinics in judicial review proceedings.
Acting in a judicial review of licences granted for the creation of human-animal hybrid embryos for stem cell research.
Securing a court declaration permitting use of a stored embryo with a surrogate following the death of a spouse, in the absence of specific consent.
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