Women in Femtech – Gilda D’Incerti – Breaking Compliance Barriers with Innovation and Global Impact

[Source - Leonardo Brogioni]

All leaders in the startup realm rapidly transform healthcare and wellness experiences for women, few leaders have made as indelible a mark as Gilda D’Incerti, a visionary founder and CEO of PQE Group. With a firm rooted in regulatory compliance and life sciences consultancy, Gilda’s leadership has not only propelled PQE Group to global recognition but also cemented her status as one of the most influential women in Femtech. Her journey is one of passion, perseverance, and purpose. A story that mirrors the very essence of what Femtech strives to achieve: impact and innovation.

From a Regulatory Expert to a Femtech Trailblazer

Gilda D’Incerti’s entry into the world of Femtech wasn’t a direct leap—it was an evolution shaped by years of experience in the highly regulated life sciences industry. After earning her academic stripes in Italy, she spent time mastering the complexities of quality assurance, validation, and compliance—skills that would become the backbone of her entrepreneurial journey.

In 1998, she founded PQE Group, a consulting company with a sharp focus on quality compliance, regulatory affairs, and technological solutions for the pharmaceutical and medical device industries. While her early years were spent demystifying GxP regulations and validation protocols, it was her growing awareness of the healthcare gender gap that ultimately ignited her interest in Femtech.

Gilda’s mission extended beyond the boardroom—she wanted to create an organization that could bridge the gap between technological advancement and women’s health. By embedding her company’s services within the broader Femtech movement, she transformed PQE Group into a global enabler of innovation in women’s healthcare.

PQE Group: Powering Compliance and Innovation Globally

[Source - PQE Group]

Headquartered in Florence, Italy, PQE Group is a women-owned, global consulting firm specializing in life sciences compliance and technology solutions. Operating across 45+ countries with more than 2,000 professionals, the company delivers customized consulting services to pharmaceutical, biotech, and medical device companies. Its unique proposition lies in offering end-to-end support in regulatory compliance, quality assurance, clinical trials management, cybersecurity, data integrity, and digital health transformation.

PQE Group’s influence spans all five continents, and it partners with both global pharmaceutical giants and agile biotech startups alike. As the healthcare industry becomes increasingly digitized and patient-centric, the firm's services play a critical role in enabling faster market access while maintaining regulatory rigor.

Under Gilda’s leadership, the company has gained a reputation for helping clients navigate the maze of international compliance standards—including FDA, EMA, PMDA, and ANVISA regulations—thus fostering safer, faster, and more inclusive innovation in healthcare.

Leadership That Redefines the Corporate Ecosystem

Gilda D’Incerti is not just a CEO—she is a transformational leader who has redefined what it means to run a purpose-driven organization. At PQE Group, inclusivity is not a checkbox—it is the culture. Over 50% of PQE’s workforce comprises women, and many hold leadership positions, creating a ripple effect of empowerment across the global organization.

Gilda champions a multi-generational, multicultural, and multidisciplinary workforce that thrives on diversity. Her leadership philosophy is rooted in collaboration, agility, and empathy—qualities that are especially crucial in the Femtech sector, where user-centric design and gender-specific research are still catching up with broader technological trends.

"Empowering women in healthcare innovation starts within the organization. If your team reflects the community you serve, your solutions will naturally follow suit," says Gilda.

PQE Group's Vision: Compliance with a Human Face

[Source - PQE Group]

PQE Group’s vision is deeply aligned with the values of Femtech—empowering human health through ethical, compliant, and innovative solutions. The company is committed to transforming the compliance narrative from a checkbox exercise into a strategic asset that fuels innovation.

Their digital health division plays a critical role in Femtech growth by helping companies design secure, regulatory-compliant platforms for solutions like menstrual tracking, fertility assistance, and telehealth services tailored to women. The team also works on cybersecurity for medical apps, data privacy, and patient-centric UX—all essential for scaling Femtech offerings globally.

In Gilda’s words, “Femtech isn’t just a category. It’s a movement. And for that movement to thrive, we need infrastructure that supports innovation without compromising on ethics or safety.”

Global Influence in the Femtech Ecosystem

While Femtech is still a relatively nascent industry, it is growing at an exponential pace—expected to reach over $60 billion by 2027. Gilda and PQE Group are well-positioned at the confluence of regulatory expertise and technological innovation, making them key enablers of Femtech expansion across borders.

PQE Group’s influence can be seen in:

• Collaborations with digital health startups focused on reproductive health, pregnancy monitoring, and hormone analysis.
• Advisory partnerships with Femtech accelerators and innovation hubs in Europe, the U.S., and Asia.
• Thought leadership and policy shaping, where Gilda often speaks about the importance of regulatory foresight in digital health innovation.

What makes PQE stand out is its localization expertise. Whether helping a startup meet HIPAA standards in the U.S. or guiding clinical trial approvals in Japan, PQE Group ensures that Femtech innovators can scale responsibly and globally.

Championing Social Responsibility and Sustainability

[Source - PQE Group]

Beyond business, PQE Group also focuses on sustainability and corporate social responsibility. The company supports education initiatives for women in STEM, provides mentorship programs, and actively engages in projects aimed at improving health access in underserved communities.

In 2021, PQE Group was recognized as a Best Managed Company by Deloitte, a testament to both its financial performance and people-first culture.

Gilda continues to lead by example, proving that you can run a profitable global enterprise while contributing meaningfully to social progress—especially in industries like Femtech that historically lacked visibility and investment.

Conclusion:

Gilda D’Incerti’s journey from regulatory consultant to global Femtech influencer is an inspiring blueprint for leaders in the life sciences and digital health sectors. Through PQE Group, she has championed a model of leadership that blends compliance, innovation, inclusivity, and global reach—all critical elements for the sustainable growth of the Femtech industry.

As more companies enter the Femtech space, they will find in Gilda and PQE Group not just a service provider, but a strategic partner committed to reshaping healthcare through the lens of gender, ethics, and technology.

In a rapidly changing world, where innovation is only as strong as the values that guide it, leaders like Gilda D’Incerti are not just participants in the Femtech movement—they are defining it.

Uncover the latest trends and insights with our articles on Visionary Vogues