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Life Sciences

The life sciences sector sits at the forefront of global innovation, driving advances in pharmaceuticals, biotechnology, medical devices, diagnostics and emerging therapeutic technologies. Organisations operate in a highly regulated environment where scientific discovery must align with strict safety, quality and ethical standards. From early‑stage research to clinical trials, commercialisation and post‑market surveillance, every phase of the development lifecycle demands precision, transparency and robust compliance. These pressures are intensified by rapid technological progress, heightened public scrutiny and increasingly complex international regulatory frameworks.

As investment accelerates across gene therapies, immunotherapies, digital health technologies and personalised medicine, companies are exploring new partnerships, data‑driven methodologies and cross‑border collaborations. This fast‑moving landscape presents exceptional opportunities for growth, but also raises intricate issues around intellectual property, data integrity, strategic partnerships and market access. Successfully navigating these challenges requires an understanding of both scientific complexity and commercial dynamics.

With global competition rising and the pace of innovation continuing to increase, life sciences organisations need clear, commercially astute guidance that supports development, protects intellectual property and ensures regulatory readiness. A thoughtful, structured approach allows companies to grow with confidence, safeguard their assets and bring transformative products to market safely and effectively.

Our team of life sciences lawyers regularly advise clients on issues such as mergers and acquisitions, joint ventures, capital investment projects, competition law, biotech/drug/pharmaceutical/medical devices development, commercial agreements, intellectual property protection, and regulatory compliance. We also advise on a wide range of day-to-day matters, including employment and pensions, procurement, disputes, health and safety, general commercial matters, and real estate transactions.

Our life sciences clients are predominantly innovator companies, manufacturers and service providers, investors, healthcare providers and research institutes, The team works with senior management, scientists and in-house legal and patent departments to deliver comprehensive and pragmatic advice.

Keystone’s Life Sciences team is made up of senior lawyers with deep sector knowledge and a proven track record of delivering commercially focused, cost-effective solutions. Recognised by leading legal directories including Chambers UK and The Legal 500, our specialists are trusted by clients for their ability to navigate complex legal challenges and add real value in a fast-moving and highly regulated industry.

Advising clients on drug and diagnostic development and clinical trials requires a deep understanding of the regulatory landscape, commercial drivers, and scientific complexity that underpin innovation in the life sciences sector. Our team of experts guide clients from concept through to clinical phases and market launch, ensuring all agreements, intellectual property protections, and collaborations are structured for success and regulatory compliance  and helping clients navigate the legal, ethical and regulatory challenges that come with testing medical products on human subjects. We ensure documentation complies with MHRA and EU requirements and Good Clinical Practice (GCP) standards. 

Experience

  • Advised a drug development company on its new project to develop cellular-based diagnostic systems for natural products. 
  • Advised a drug-discovery and development-services company on a collaboration agreement with a global company that produces speciality chemicals that are used in some of the biggest, most successful brands in the world. 
  • Defending a pharmaceuticals manufacturer in a claim arising from a clinical drug trial.  
  • Supported a multinational company on global clinical trials, including contracting with CROs, suppliers, and hospital sites.  
  • Acted for the London School of Hygiene and Tropical Medicine in litigation concerning the conduct of a clinical trial.  
  • Advised a provider of clinical trials services on various contractual disputes with sponsors.  
  • Acted for a biotechnology company in a dispute with a supplier concerning a defective clinical study.  
  • Commercial contracts for a laboratory testing company for clinical trials testing including template services agreement, service level agreement and global courier agreement.   
  • Overhauling the clinical development contracting structure for various multinationals.   
  • Formed and developed a new legal department for a substantial FTSE 250 drug delivery company, including acting as general counsel on an interim basis. Managed the development of new commercial, regulatory and compliance procedures. 
  • Advised on numerous biopharmaceutical Development and Manufacturing Services Agreements (DMSAs) and the accompanying Quality Agreement.   

Team

We have the deep industry knowledge required to advise on Bribery Act compliance in the life sciences sector, ensuring that corporate policies and practices address procurement risks, overseas partnerships, and NHS engagement. 

Experience

  • Instructed by a global pharma group to review and analyse the company’s UK third-party supplier oversight and bribery and corruption compliance programmes.   
  • Conducted a bribery risk controls gap analysis for a global pharmaceutical company. 

Team

Our experienced banking and finance lawyers closely with life sciences clients to guide them through complex finance arrangements in regulated markets. They provide rapid, strategic advice in response to capital investment in life sciences manufacturing and R&D infrastructure, providing advice on loan structures, security arrangements, and ensuring compliance with sector-specific financial regulations. 

Experience

  • Advised a German technology VC fund and life science VC fund on their Shariah-compliant term notes. 
  • Advised developing startups in bio-regenerative medicine on suitable setup vehicle and methods of raising capital.   
  • Advised Proteome Sciences plc (AIM) on equity fund raising, shareholder loans and corporate governance.  
  • Advised Swarraton Partners on its private equity investments in Revolymer and Theragenetics.  
  • Prepared a policy paper for HMG on the development of bio-regenerative medicine to inform development of policy for HMG investment in the sector.   
  • Set up funds for a specific platform for investment in the bio-tech and bio-regenerative medicine sector.  
  • Various trades in the life settlement space using cohorts as an asset class for investment and as collateral for loans.   
  • Advised F2G on multiple venture capital financings, including its $70m Series H round.   
  • Advised various biotech and medtech companies on convertible loan financings from the Future Fund.   
  • Advised AIM listed Abzena on its IPO, various secondary financings and takeover.   
  • Advised AIM listed TheraCryf on its IPO and various secondary financings.   
  • Advised AIM listed Oncimmune on venture debt and equity financings.   
  • Advised Puridify on a Series A round and its subsequent acquisition by GE Healthcare. 

Team

With proven expertise in advising on collaboration agreements tailored to the life sciences sector, our life sciences lawyers assist clients in negotiating and drafting research and development (R&D) partnerships, licensing arrangements, and joint ventures. Our team ensures compliance with regulatory frameworks, addresses intellectual property considerations, and aligns agreements with commercial objectives. With deep sector knowledge, we deliver pragmatic solutions that facilitate innovation, protect proprietary assets, and support our clients growth in the competitive landscape. 

Experience

  • Acted for Absynth Biologics on research collaboration agreement with Morphosys AG relating to Staphylococcus aureus infections including MRSA.   
  • Advised a gene therapy delivery company on its research collaboration with a US public benefit corporation.   
  • Advised a life sciences genome company on patent and know-how licensing agreements, including licences out and collaboration agreements.   
  • Advised a pharmaceutical manufacturer on a technology collaboration agreement with a commercial customer.   
  • Advised a plant sciences company specialising in gene editing on long term collaboration agreements with leading, multinational agriculture companies. 
  • Advised a US-based medical device developer on IP due diligence matters, patent assignments and ongoing joint venture and collaboration agreements in the UK, US and Asia. 
  • Advised an award-winning life sciences client on the subsistence of copyright and related rights in software, software licensing, collaboration agreements and enforcement of its rights. 
  • Advised on collaborations in the development of diagnosis of Alzheimer’s.   
  • Advised on entitlement to inventions and collaboration concerning COVID-19 vaccines.   
  • Advised one of the leading research institutes in Europe on an ongoing basis on licensing, spinouts, collaboration and R&D agreements with multinationals, educational institutions and SMEs. 
  • Advised on a joint venture established for the global manufacture of biosimilars.   
  • Advising on the competition law implications of JVs in both the pharmaceutical and medical device sectors. 

Team

Our highly specialist lawyers advise on all aspects of distribution and manufacturing agreements for pharmaceutical products across the life sciences industry. We ensure the allocation of rights and responsibilities reflects market realities, protects regulatory compliance, and safeguards brand and product reputation. 

Experience

  • Developing for a major pharmaceutical manufacturer a suite of standard form agreements, including agreements relating to the manufacture of biologicals and biosimilars.   
  • Advised a London-based life science spinout from a US headquartered multinational pharmaceutical company on licensing and manufacturing agreements in Europe, the US and Asia.   
  • Advised a wound products manufacturer on various disputes.   
  • Advised on a joint venture established for the global manufacture of biosimilars.   
  • Instructed by a UK pharmaceutical manufacturer and its shareholders in relation to breaches of UK export controls over a significant period of time.  
  • Advising on EU competition and compliance for a large generic pharmaceutical manufacturer.  
  • Advised a global pharmaceutical contract development company on its pharmaceutical manufacturing agreement with a biopharmaceutical company that develops transformative solutions for patients and in particular on issues relating to the sub-licence of technology from a university and how to address risks related thereto.  
  • Advised the CEO of pharmaceutical company on the renegotiation of his agreement with a research-based pharmaceutical company under which they were the exclusive distributor of certain products in Greece and Cyprus. 
  • Advised a cancer specialist company in relation to its distribution agreement with a research and development company relating to its new cancer diagnostic kit. 
  • Developed a model distribution agreement for the distribution of a leading company specialising in wound-healing medical devices. 
  • Acted for major European listed pharmaceutical company in relation to a dispute under a distribution agreement for a pharmaceutical product. Claim value: US$30 million.  
  • Advised a LSE listed pharmaceutical company in relation to various distribution agreements; advices included ability to rely on a limitation of liability clause for alleged deliberate breach of the agreement, and the amount of compensation payable under the Commercial Agents (Council Directive) Regulations.  

Team

Advising on commercial relationships in the life sciences sector demands specialist insight. Our lawyers draft and negotiate tailored terms and conditions that protect our clients’ interests, including procurementconsultancy material transfer and confidentiality arrangements as well as regulatory compliance and dispute resolution.  

Experience

  • Drafted suite of template documents for major clinical research organisation.   
  • Advised a leading Portuguese research body on its commercialisation strategy.   
  • Advised on the creation of a royalty monetisation programme.   
  • Acted in major product acquisitions for various clients.   
  • Advised on various co-development agreements with biotechnology companies and big pharma including Apitope and Merck Serono.   

Team

Our commercial property experts provide strategic advice to biotech firms, pharmaceutical companies, and research institutions in acquiring, developing, and managing specialised facilities, including laboratories and R&D centres. We ensure compliance with regulatory requirements, advise on planning and zoning issues, and support clients through complex transactions. 

Experience

  • Acted for a (now NASDAQ listed) life science company in the acquisition of multiple leasehold property interests at Milton Park, Oxfordshire. 
  • Acted for a clinical stage biopharmaceutical company on its acquisition of numerous UK property interests including its Oxfordshire-based research and development facility.  
  • Acted for a publicly listed pioneering clinical stage T Cell receptor biotechnology company on its acquisition of all its UK-based property interests.   
  • Acted for Fluorogenics Limited (a subsidiary of New England Biolabs) on its acquisition of new laboratory premises in Milton Park.   
  • Acted for Karus Therapeutics on their exit and surrender of lease at Harwell Science Park.   
  • Advised Vaxequity Limited, a spinout from Imperial College, on the acquisition of its first laboratory space on Cambridge Science Park.   
  • Drafted and negotiated professional appointments and design and build works contracts and security documents on multiple commercial developments on Milton Park Oxfordshire for the development and expansion of a life sciences sector for research and other facilities. 

Team

We understand how competition rules affect life sciences operations, particularly around market dominance, pricing, exclusivity, and access to markets. Our team’s extensive experience in providing strategic guidance on competition law enables clients in the life sciences sector to structure collaborations, merger and acquisition (M&A) activity, and pricing models in order to achieve growth without breaching UK and EU competition rules. 

Experience

  • Instructed by a UK pharmaceutical manufacturer and its shareholders in relation to breaches of UK export controls over a significant period of time.  
  • Advising on EU competition and compliance for a large generic pharmaceutical manufacturer.  
  • Advising on EU advice relating to pharmaceutical and food labelling and borderline food/pharma issues.   
  • Advising on the competition law implications of JVs in both the pharmaceutical and medical device sectors.   
  • Advising on competition law and regulatory implications of generic and proprietary pharmaceutical pricing.   
  • Advising a medical devices company on strategic and market issues relating to suppliers with a dominant market position. 

Team

Our corporate experts advise on a broad range of corporate formation and governance issues, helping life sciences organisations understand and comply with Companies Act requirements, particularly in complex regulated ownership structures. Our team also advises on mergers, demergers, and internal restructurings, facilitating seamless transitions and risk mitigation, supporting clients’ growth and adaptability in a dynamic life sciences landscape. 

Experience

  • Advised Proteome Sciences plc (AIM) on equity fund raising, shareholder loans and corporate governance.  
  • Advised a global medical devices company on post-diligence mitigation approach and strategy in its China business. .  
  • Advised Investec as nomad and broker to LungLife AI Inc on the latter’s AIM admission and placing.  
  • Advised a large orthopaedic company on a new scheme for compensating inventors, some of which were orthopaedic surgeons, creating new medical devices (replacement hips, knees, etc.) for them involving share options. 

Team

Our corporate lawyers have years of experience of providing expert legal support to pharma, medtech and biotech firms across all aspects of M&A, including due diligence, regulatory approval, and integration. 

Experience

  • Advised the shareholders of Oxgene, on the sale of the company to WuXi AppTec.   
  • Advised AIM listed LiDCO on its takeover by Masimo Corporation.   
  • Advised AIM listed 4D Pharma on various secondary offerings and its merger with Longevity Acquisition Corporation.   
  • Advised the shareholders of Brabant Pharma on its acquisition by Zogenix.   
  • Acted for Neuraxpharm on its acquisition of the pharmaceuticals portfolio of Glenmark Poland.  
  • Acted for Aculive on its Series A investment by Bitbio.   
  • Acted for ABC Medicover in its equity investment in fertility clinic RHG.   
  • Acted for Omnicell, Inc on its acquisition of pharmacy automation business Surgichem, a BUPA subsidiary.   
  • Acted for Nordic diagnostics company Orion Diagnostica Oy on its acquisition of Geneform Technologies Limited.   
  • Acted for Tularik Inc on its acquisition of the computer-aided molecular design business of Protherics Ltd.   
  • Acted for BEI Technologies Inc on the acquisition of the business of Newall Measurement Systems Ltd, a digital readout and linear encoder business.   
  • Acted for Lynx Therapeutics Inc on the $155m reverse takeover all share offer with Solexa Ltd.   
  • Acted for Gen-Probe Inc on its acquisition of the MLT group of companies.   
  • Acted for Zeus Capital as Nomad for Venn Life Sciences plc on a reverse takeover and fundraising. 
  • Acted for Neuraxpharm on its acquisition of STU GmbH, a cannibidiol distribution business.   
  • Advised a Russian private equity fund on a $220m disposal of a pharmaceutical company to a Finnish listed healthcare company. 
  • Advised life sciences compliance software company Ennov on the UK aspects of its strategic acquisition of CALYX’s Enterprise Technology division. 
  • Provided specialist IPR advice to IMS Health in connection with their acquisition of UK-based healthcare data analytics company Dataline Software. 
  • Advised Pharmstandard, the leading Russian pharmaceutical company, in relation to a spin-off of its OTC business.  
  • Advised Sanofi on its acquisition of a major Russian insulin manufacturer.   
  • Advised Lupin on the acquisition of a Russian generics manufacturer.   

Team

Our IP and data protection specialists advise NHS bodies, private providers, and life sciences companies on navigating complex regulatory frameworks, including GDPR and the Data Protection Act 2018. We support clients with data processing agreements, subject access requests, and breach management, delivering clear, pragmatic advice that safeguards personal data and upholds patient confidentiality. 

Experience

  • Acted as data protection officer for a company carrying out research in life sciences, supporting its growth from a startup, through its funding cycles and eventual sale. 
  • Advised US-UK researchers on the use of medical data, and lectured at the Texas Medical Center on data use.   

Team

We support life sciences providers, suppliers, and investors in resolving disputes quickly and efficiently. Whether contract, IP or regulatory in nature, our focus is on practical outcomes aligned with business goals. 

Experience

  • Defended a complex discrimination claim against a life sciences company. 
  • Advised a wound products manufacturer on various disputes.   
  • Advised a multinational life sciences company on contractual claims made against it by an employment agency. 
  • Advised on numerous high-value patent litigation settlements.   
  • Acted for a major European listed pharmaceutical company in relation to a dispute under a distribution agreement for a pharmaceutical product. Claim value: US$30 million.   
  • Advised a listed Australian company in relation to its obligations pertaining to a dispute between a party that had conducted research into the application of a specific drug, and with which the company had contracted to bring the application of the drug to market, and a party that had previously sought to bring the drug to market. Claim value in excess of US$10 million.   
  • Handled the UK portion of an international trade mark dispute between a medical devices company and a technology company.   
  • Acted for a distributor of a pharmaceutical product against a contracting party in relation to the assertion that it had failed to satisfy its regulatory obligations in the distribution of licensed products to the market. Contract value: £2 million.   
  • Advised a small pharmaceutical company in relation to a dispute with a larger pharmaceutical company in relation to royalty payments under a pharmaceutical licensing agreement. 
  • Acted for an investor who invested £2.6m in an IT company that purported to have been awarded National NHS Framework Agreement. The client brought a claim for fraudulent misrepresentation and breach of warranty when it transpired that the business had not been awarded the contract and the documents provided on due diligence were misleading.  
  • Acted for and advised an English company and trade mark owner of a life science product in relation to a royalty payment dispute with a global pharmaceutical company under a 30-year licence agreement pertaining to that product. The claim focused on the definition of ‘net sales value’ by which the royalty sum was calculated. Claim value: £15 million.   
  • Advised a LSE listed pharmaceutical company in relation to various distribution agreements; advices included ability to rely on a limitation of liability clause for alleged deliberate breach of the agreement, and the amount of compensation payable under the Commercial Agents (Council Directive) Regulations.   
  • Advised on issues arising between life sciences companies and animal rights protestors.  
  • Acted for a manufacturer of oncology scanning devices in litigation with its Chinese distributor.  
  • Advised on legislative changes and compliance, for example in relation to innovations concerning diagnostics and treatment of chronic conditions.  

Team

Our employment specialists have extensive experience advising life sciences organisations on all aspects of employment law. From clinical staffing arrangements and TUPE transfers to disciplinary matters and whistleblowing investigations, we provide clear, pragmatic guidance tailored to the unique challenges of the sector. 

Experience

  • Advised a US-owned, UK-based medical devices business on post-termination restraints in respect of a number of senior and sales executive recruitment decisions.   
  • Extensive day-to-day advice for a multinational business in the pharmaceutical logistics sector.   
  • Provided expert assessment on whistleblowing risks to a major US pharmaceutical business.   
  • Defended a complex discrimination claim against a life sciences company. 
  • Advised a privately owned bio sciences business on executive severance arrangements.   
  • Worked with the in-house team of a research institute on collaboration agreements underpinned by secondment arrangements.   
  • Advised an international life sciences company on the tax aspects of employment status and IR35.  
  • Acted for a Canadian life sciences company in drafting and negotiating contracts for the fit-out works and related consultancy services at its new UK head office. 
  • Supporting a pharmaceutical client’s in-house legal and privacy teams with a pre-litigation subject access request advice and working with their e-disclosure team to assess relevance, commercial risks and third-party privacy issues.   
  • Advised a large global non-profit life science organisation on the tax implications associated with the recruitment of a US senior executive to work in the UK.  
  • Advised a start-up life sciences company with the tax implications associated with recruiting non-UK nationals and provided advice to new recruits.  
  • Advised an Oxford-based life science company on the participation of US nationals in a UK EMI arrangement.   
  • Advised a Cambridge-based life science company through a voluntary disclosure to HMRC with respect to an employment tax compliance failure. 

Team

Our team have proven expertise in advising on all aspects of intellectual property in life sciences. From patent protection and data exclusivity to enforcement and strategy, we support clients in maximising the value of their biotech, pharmaceutical, and medical technology innovations and maintaining a competitive edge. We assist with licensing, spin-outs, patent filings, and dispute resolution to help clients extract full value from their innovations and the commercialisation of research and development (R&D) outcomes. 

Experience

  • Represented Pfizer Inc on copyright advisory and internet domain name dispute issues.   
  • Represented Lloyds Pharmacy in trade mark portfolio management matters.  
  • Represented Novartis AG in trade mark clearance and branding matters.   
  • Successfully defended entities in the Sandoz group against an alleged registered trade mark infringement and passing off claim in the High Court brought by the Glaxo group regarding the use of the colour purple per se for a dry powder inhaler used to deliver a generic version of Glaxo’s multi-billion-dollar blockbuster asthma/COPD drug, Seretide.   
  • Represented Bristol-Myers Squibb Company in pharmaceutical trade mark clearance, filing, prosecution, and maintenance matters.   
  • Advised a medical device company on a series of design disputes.   
  • Advised a multinational bio-pharmaceutical company on trade mark and domain name issues.   
  • Advised a multinational in the pharmaceutical industry on trade mark and domain name disputes in relation to a well-known branded product.   
  • Advised a pharmaceutical company on multiple multi-jurisdictional patent infringement and validity disputes.   
  • Advised a publishing company in the pharmaceutical industry in connection with trade mark, passing off, copyright and domain name issues.   
  • Advised a biosciences company on the exploitation of the UK Patent Box legislation and drafting and advising on commercial agreements required to take advantage of the Patent Box. 
  • Advised a biotechnology company on the assignment of all rights in a cell line going to them and a licence to the related antibody. 
  • Advised a British pharmaceutical chain in a patent dispute in connection with ocular equipment.  
  • Advised a cosmetics company on regulatory compliance issues across the EU in parallel with US advice as well as on branding and other IP issues.   
  • Advised a leading biotechnology company on a patent dispute relating to stem cell technology.   
  • Advised a leading firm of London patent attorneys on a patent licence taking into account the complex history of the parties.   
  • Advised a life sciences technology provider on regulatory compliance and IP enforcement issues.   
  • Advised a listed UK plc on the IP and contractual aspects in relation to the transfer of a large portfolio of life science agreements including ongoing R&D arrangements, licences, patents and trademarks.   
  • Advised a start-up diagnostics company spun out from a university on trade mark and design protection matters for a medical device.   
  • Advised an award-winning life sciences client on the subsistence of copyright and related rights in software, software licensing, collaboration agreements and enforcement of its rights.   
  • Advised a biotechnology company on a worldwide licensing agreement in relation to a proprietary antibody which has applications for the treatment and diagnosis of disease.   
  • Advised an innovative company on cell line licences required for the development of its proprietary biological medicines.   
  • Advised an innovative diagnostics company on a suite of significant agreements relating to the research, development and exploitation of its epigenetic biomarker technology.   
  • Advised on numerous patent and know-how licences relating to cell lines.   
  • Advising the client on the IP strategy of their brand for entry into China. The brand is an eco-health supplement brand based in the UK.   
  • Carried out a number of UK trade mark clearance search projects and associated filing work for a US healthcare company focused on glucose monitoring.   
  • Handled international design protection strategy and filing work for a global medical products and technologies company focused on the management of chronic conditions.   
  • Provided freedom to operate advice to a multinational pharma and biotech company in relation to inhaler products.  

Team

Our experienced team assist biotech firms, pharmaceutical companies, and research institutions in negotiating and drafting licensing agreements that facilitate the development and commercialisation of innovative products. Our specialist lawyers advise life sciences clients on all aspects of technology licensing, including agreements for patented technologies, software, and proprietary know-howWe ensure compliance with regulatory requirements, address intellectual property considerations, and align agreements with our clients commercial objectives, supporting their growth and innovation in the life sciences industry. 

Experience

  • Advised a leading Irish-based, US-venture-backed biotech startup on a number of licensing arrangements with UK and US educational institutions and charities.   
  • Advised a London-based life science spinout from a US headquartered multinational pharmaceutical company on licensing and manufacturing agreements in Europe, the US and Asia.   
  • Acted for Decibel Insight on the SaaS licensing of its web optimisation software.   
  • Advised a biotechnology company on the licensing of its patent-protected technology in Japan.  
  • Advised a listed biotechnology company on the exclusive worldwide licensing of its drug delivery technology to a major pharmaceutical company.   
  • Advised a synthetic plant biology company on its collaboration and licensing agreements relating to its technology.   
  • Advised an award-winning life sciences client on the subsistence of copyright and related rights in software, software licensing, collaboration agreements and enforcement of its rights. 
  • Advised a UK antibody innovator company on a global patent and know-how licensing deal with a major pharmaceutical company.

Team

Our team advises life sciences clients on managing product liability risks across pharmaceuticals, medical devices, and healthcare products. We provide strategic guidance on compliance, crisis management, and litigation, ensuring robust protection against claims and safeguarding reputation in a highly regulated environment. 

Experience

  • Advised on product liability involving medical devices, pharmaceuticals, electrical products, food, kitchen equipment etc. which, among other products customarily used in care homes, can cause injury or death if defective or negligently used or dispensed.   
  • Defending a pharmaceuticals manufacturer in a claim arising from a clinical drug trial.  
  • Acted for the supplier of a construction locomotive in an inquest and civil claim following a double fatality on the Channel Tunnel Rail Link project.   
  • Successfully represented an international manufacturer of white goods on fire damage & complex injury claims.  
  • Assisted in the handling of various high-profile product crises and product liability claims such as serotonin, antidepressants and various NSAIDs.   

Team

Our life sciences lawyers provide strategic advice on regulatory matters tailored to the sector’s unique needs. We assist biotech firms, pharmaceutical companies, and research institutions in navigating complex regulatory frameworks, including compliance with MHRA and EMA guidelines. Our team supports clients through the entire product lifecycle, from development and clinical trials to market authorisation and post-market surveillance. With deep sector knowledge, we deliver pragmatic solutions that ensure compliance and support our clients’ innovation and growth. 

Experience

  • Advised on regulations relevant to new pharmaceutical products.  
  • Advised a life sciences technology provider on regulatory compliance and IP enforcement issues. 
  • Advised Northampton-based Otago Healthcare regarding the launch of pharmaceutical products into the UK market.  
  • Advised on the Medical Device Regulations post-Brexit.   
  • Advised the government of an EU Member State on establishing PCR testing infrastructure during the COVID-19 crisis.   
  • Advised on regulatory matters relating to biopharmaceutical facility inspections by the FDA, MHRA, and other regulatory bodies.   
  • Acting in various appeals against adverse NICE decisions.   
  • Provided European regulatory support for multi-billion dollar/pound worldwide deals including for companies such as GE Healthcare and BTG.

Team

Our tax specialists provide strategic advice to life sciences organisations on complex employment and corporate tax matters. From international recruitment and EMI schemes to compliance with HMRC regulations, we deliver practical, commercially focused solutions that mitigate risk and support growth in a highly regulated environment. 

Experience

  • Advised a large global non-profit life science organisation on the tax implications associated with the recruitment of a US senior executive to work in the UK.   
  • Supported a start-up life sciences company with the tax implications associated with recruiting non-UK nationals and provided advice to new recruits.   
  • Provided tax advice to an Oxford-based life science company on the participation of US nationals in a UK EMI arrangement.   
  • Supported a Cambridge-based life science company through a voluntary disclosure to HMRC with respect to an employment tax compliance failure.   
  • Advised an international life sciences company on the tax aspects of employment status and IR35.

Team

Please note: The experience list above may include examples of work completed prior to joining Keystone Law.