What can I do for you
Stephanie brings deep sector expertise and practical legal insight, honed through years of in-house experience at leading life sciences organizations. This unique background gives her a clear understanding of the commercial realities her clients face, enabling her to deliver strategic, pragmatic advice aligned with business objectives.
Her work involves helping clients navigate complex regulatory and compliance frameworks, manage risk, and make informed decisions in their growth journey. Stephanie’s expertise spans:
- Intellectual property licensing and strategy
- Data protection and privacy compliance
- Research collaborations and consortium agreements
- International commercial arrangements, including distribution and manufacturing
Supporting your ambitions
For over a decade, Stephanie has guided clients through some of the most significant challenges in the life sciences sector, including global responses to epidemic and pandemic threats. Her experience includes:
- Advising clients on and negotiating complex multinational research consortium agreements in the field of vaccine development.
- Working closely with clients on connected development, licence and supply agreements for their product development pipeline to ensure that the licensed rights and grant timeframe corresponded with their planned product authorisation and launch.
- Supporting clients in the review and negotiation of contracts with manufacturers to make sure an alternative source of supply for the active ingredients to their medicinal products.
- Working with international life sciences businesses to ensure compliance with UK and EU GDPR requirements for their clinical research programmes.
- Providing strategic input around regulatory and commercial requirement for launches of online business models, including online distribution of over the counter medicines, medical devices and telemedical services.
- Advising on borderline issues for products in health and medical technologies, medicines and cosmetics, in particular how positioning in the market could impact on regulatory classification.
- Supporting clients with fulfilling regulatory compliance requirements connected to incident management (e.g. suspected adverse events, device defects, MHRA enforcement letters).
Stephanie is also a recognised specialist in medical device (including SaMD and AIaMD) regulation, frequently invited to speak at UK and international conferences.
What do others say
The head of data privacy at a global life sciences company said Stephanie has “all it takes to successfully counsel” her clients.
What else should you know
Examples of Stephanie’s work include:
- Working as part of the GSK team on the negotiation of vendor and technology contracts relating to its spin off of the Haleon (consumer health) business
- Advised the Cabinet Office and the Department of Health & Social Care during the Covid pandemic on urgent projects to deliver innovative Covid-19 technologies, including advising on the Ventilator Challenge, the procurement of lateral flow tests, and the research under grant funding of novel Covid-19 testing methods via mass spectrometry.
- Supporting a range of clients in the preparation, review and mark-up of international data sharing arrangements (including privacy notices and informed consent forms) and data protection compliance programmes in particular in connection to multi-national clinical research programmes. This included negotiating multiple site agreements and tracking variations in local jurisdictions through our M&R Global network.
- Advising a range of pharmaceutical companies and NHS organisations on ABPI Code compliance issues, including in connection with structuring and the supporting documentation in relation to collaborative working and joint working arrangements.
- Supporting a client on the preparation of NDAs, MTAs and similar contractual documents relating to its research collaborations (including for international shipment of CL4 materials during an Ebola outbreak).
- Advising a European manufacturer of medical devices and cosmetic products on borderline issues and reviewing and advising on its promotional materials and social media campaigns in relation to regulatory compliance.
Stephanie is passionate about advancing FemTech and women’s health innovation. She works closely with our technology team and health and care team and actively supports our FemHealth Focus campaign, helping clients overcome regulatory and commercial hurdles to bring transformative solutions to market.