I provide guidance on the range of issues that arise through a product's commercialisation, including product authorisations, clinical research, advertising, regulation of human tissues and transport of cells into/out of the UK (for example cells for ATMPs).
I advise clients on compliance programmes, the UK ABPI Code and PMCPA matters. I have assisted clients by preparing and training on business compliance policies. I have also provided support to clients in relation to alleged breaches of the Code and complaints to the PMCPA. I also advise on transparency and reporting requirements.
I draft commercial agreements that are key to clients' business operations, incorporating appropriate commercial and regulatory solutions. For example, licensing and collaboration agreements, agency and distribution agreements, consultancy agreements, contracts for goods and services, customer order terms and conditions and clinical trial agreements.
My expertise includes acting on corporate M&A and venture capital transactions in the life science sector, as well as other technology and IP rich business sectors. I have assisted with due diligence, contract disclosure, and IP matters.
What others say…
Life sciences regulations, patent litigation and corporate advice are the standout specialties of Fieldfisher in this sphere. The regulatory team is led by Alison Dennis, who is supported by John Cassels and associate Nicola Bex