We act for Medical Device and In Vitro-Diagnostic companies at all stages of their commercial life-cycle. We place particular emphasis on ensuring that regulatory and legislative obligations for all parties are clearly defined and set out within our bespoke Commercial Agreements.
We offer tailored advices in the following areas:
Advices in relation to the correct corporate structure;
Protection of Intellectual Property and ensuring a good chain of I.P. title;
Licensing of technologies;
Collaborative Research and Development Agreements;
Appointment of Distributors;
Sub-contract and Outsourcing arrangements;
Competition Law issues;
Legalisation and Authentication of documentation;
Advices regarding interaction with HCP’s;
Labelling and Packaging advices;
Regulatory, Data Protection and Privacy issues; particularly in relation to Clinical Investigations;
Product Liability issues.
For clients involved in the Pharmaceutical industry, we regularly negotiate and draft a wide-range of Commercial Agreements including non-disclosure, toll manufacturing, licensing, distribution, confidentiality, clinical trial, research and development collaborations and other arrangements. We ensure that key rights and obligations such Intellectual Property, GCP and GDP are clearly agreed and defined within Commercial Agreements. We support our clients from the early stages of pre-clinical research and clinical trials, manufacturing and marketing and distribution of their products. We advise on registration, licensing, good clinical practice, export, advertising and marketing of medicinal products, interaction with health-care professionals and regulatory authorities, packaging and labelling, pharmacovigilance, data protection, pricing and product liability.
The rapid evolution of the ‘Internet of Things’ as well as the continued growth of Mobile Medical Applications has meant that we increasingly act for companies developing mobile devices, such as mobile phone applications, patient monitoring devices, personal digital assistants and other wireless devices. We regularly assist I.T. clients and companies in determining whether their software may be regulated as a medical device and work with their advisors to determine an appropriate regulatory strategy for their business.The following work is also critically important for clients in this sector:
Software Development Agreements, SaaS Subscription Agreements, Data Protection advices and Consultancy and Employment Agreements aimed at protecting and securing ownership of intellectual property.
We provide legal advice to food supplement and other nutrition companies. We regularly advise and provide assistance in the following: labelling & packaging, research and development collaborations, health & nutrition claims, product liability, CE marking, advertising & sales promotion, appointment of distibutors and negotiation and drafting of endorsements agreements.
We have negotiated and drafted commercial agreements for companies involved in the research and development of innovative devices designed to monitor disease and increase production in agriculture. Joint-venture collaboration agreements, research collaborations with publicly-funded organisations, supply agreements and confidentiality agreements are relevant to this sector. Through our work we have also developed an expertise in the area of GMO legislation/regulation and biotechnology legal issues relevant to the sector.
Contract Manufacture and Supply Chain
Acting for contract manufacturers of medical devices, distributors of pharmaceuticals, specialised cleaners of sterilised environments and other third-party providers requires expert knowledge of their respective legal and regulatory responsibilities. We have developed expertise which we use to protect our clients' interests by clearly defining their obligations in commercial agreements such as third-party supply agreements, design services agreements, toll-manufacturing agreements, contracts for services, distribution and agency agreements.