Regulatory Science for Patient-Centred, Substance-Based Women’s Health Technologies

Fempharma is an ISO 13485-certified women’s health micropharma providing real-world regulatory science input to support the translational development of patient-centred health technologies, with a particular focus on substance-based medical devices and borderline products.

Women’s health represents one of the most regulatorily complex and under-served domains in healthcare innovation. Products frequently fall between medicinal products, medical devices, and food supplements, while traditional clinical endpoints often fail to capture patient-relevant outcomes such as quality of life, recurrence prevention, sexual health, cognitive function, or postpartum recovery.

Fempharma contributes hands-on experience across:

• MDR classification and conformity assessment of substance-based medical devices

• Borderline product positioning (device vs supplement vs medicinal)

• Integration of real-world evidence and post-market surveillance into regulatory decision-making

• Translational pathways from academic discovery to CE and FDA readiness

• Patient-centred outcome definition in women-specific conditions

Women’s health is used as a model regulatory environment to test, refine, and generalise regulatory science approaches applicable to other patient-centred health technologies.

Role in consortium

• SME providing applied regulatory science case studies

• Contributor to guidance, methodologies, and best practices

• Bridge between academia, regulators, and industry

• Exploitation and policy-impact partner