While women’s health research has been historically overlooked and underfunded, in recent years there has been a surge of activity amongst researchers, investors and policymakers focusing on promoting women’s health and closing the gender health gap.

Women’s health, meaning female-specific diseases as well as general health conditions that affect women differently or disproportionately, is being increasingly recognised as a field in its own right.  

Our experts here at Bristows regularly advise on many of the complex and varied issues faced by companies operating in the women’s health space. Our Women’s Health Initiative strengthens our long-standing legal support of femtech pioneers, pharmaceutical innovators, medical device manufacturers, academic research bodies, and investors working in women's health. As a world class IP, regulatory, and commercial law firm, we are at the forefront of the legal issues that matter to this vital sector. 

Our expertise

Bristows is proud to be working in the women’s health sector - helping clients to navigate the commercial, legal and regulatory challenges that they may face in bringing new therapies and solutions to market, to close the gender health gap. We support clients across this sector and provide a range of advice, including:

• Regulatory advice: on clinical trials/clinical investigations, medical device and IVD qualification and classification, EU MDR/IVDR, AI Act , and UK/EU market “approvals”;
• IP & commercial strategy: including licensing, R&D collaborations, consortium and joint-venture agreements;
• Corporate and finance support: from spin-out deals and funding rounds to joint ventures and exits; and
• Data protection guidance: particularly for GDPR-compliant femtech and digital health solutions.

Our clients include:

• Femtech innovators: navigating device qualification, classification, AI regulation and compliance;
• Medical device developers: including those working with in vitro diagnostics, including companion diagnostics;
• BioPharma companies: developing “orphan” products addressing unmet needs in the field of women’s health, paediatric programs, and supply chain logistics;
• Academic and research institutions: externalising cutting-edge technology via spin-outs, partnerships and licensing programmes; and
• Investors: identifying opportunities and providing growth capital for the development of women-centric therapies and technologies.