Regulatory pressure on pharmaceutical manufacturers to maintain compliant supply chains is growing. With growing cost-cutting pressures also large, pharma companies are increasingly turning to external providers to manage supply chain compliance in this new environment.
Qualifyze, the cloud-based audit data and application platform, serves more than 1,000 clients and has built the largest dataset of validated quality compliance audit statistics across the pharmaceutical industry.
Additional investment from HV Capital along with fresh funding from US-based HarbourVest Partners and Italy-based H14 to further drive internationalization and product development efforts.
Qualifyze, a trusted name in the pharmaceutical supply chain compliance space, has announced a $12m funding round while tracking toward $10m+ ARR in topline growth, continuing its 100% year-over-year growth trajectory. This milestone marks a significant step forward as Qualifyze focuses on enhancing its cloud-based audit data and application platform connecting customers, suppliers, and auditors to track, monitor, and forecast quality and sustainability compliance adherence in the pharmaceutical sector.
Faced with increasing pressure from regulators to maintain safe and compliant supply chains and a growing need to reduce costs, pharmaceutical companies are increasingly leveraging outsourced service providers to address the need to regularly audit their suppliers. These audits are largely pen-and-paper based with little technological support and any data generated is not leveraged further following the audit.
Since its launch in 2019, Qualifyze has audited thousands of suppliers, going beyond the traditional file-and-forget audit report mentality. By capturing audit data at scale and offering a digital platform to manage audits end-to-end, Qualifyze has already supported more than 1,000 pharmaceutical manufacturers to improve supply chain compliance and reduce supplier qualification costs.
Recently, Qualifyze also launched its “Supplier Intelligence“ suite, providing pharmaceutical companies with statistics on supplier compliance levels and audit observations to predict trends and develop compliance risk mitigation strategies.
“The speed of our growth and our continued success is proof of the value we are generating for our clients,” says Dr. David Schneider, CEO & Founder of Qualifyze. “We are not just transforming how supplier audits are being performed. Qualifyze is creating a new category of compliance data, which will allow our clients to make more informed decisions to increase drug safety for their patients and to better allocate investments into supply chain compliance, even beyond GxP. This funding will help us accelerate our mission to transform supply chain compliance in healthcare in a sustainable, data-driven manner.”
Existing investors HV Capital and Rheingau Founders and new investors HarbourVest Partners and H14 participated in the $12m round to accelerate the transition into an end-to-end supply chain compliance data platform.
“Since our initial investment, Qualifyze achieved nothing less than becoming the global leader in quality compliance data of today’s pharmaceutical industry.” says Felix Klühr, Partner at HV Capital and one of Qualifyze’s first investors. “Serving 1,000+ pharmaceutical clients and more than doubling every year in a profitable manner is both a testament to the quality of the team and the regulatory tailwinds towards a harmonized quality approach in life science. We’re excited that the team chose to continue partnering with HV as part of HV’s strategy to provide the company with early and growth capital from initiation to IPO.“
With ~80% of its customers outside of Germany and ~20% outside of Europe, Qualifyze already set the foundation for a global business model with proven international success. The additional capital will also be leveraged to continue its expansion within existing and into new geographic markets to become the supply chain compliance data platform of reference in the pharmaceutical industry.
Joel Hwang, Managing Director at HarbourVest Partners, says: “At HarbourVest Partners, we have supported, alongside our general partners, many leading venture and growth businesses for decades across Europe and the Americas. Qualifyze stands out as an emerging leader in a space with tremendous potential for digital transformation. Their platform drives significant efficiencies for pharma companies in their audit processes and has the potential to become the platform of reference in this sector and many others. We are excited to back Qualifyze as they accelerate their expansion plans.”
Since its launch in 2019, the Frankfurt-based company has been committed to supporting pharma companies with fast, flexible, and reliable supply chain compliance assessments. With a global network of over 200 local expert auditors, 1,000+ pharma clients, and the world’s largest database of supplier compliance data from 2,000+ suppliers, Qualifyze has emerged as the leading provider of structured and analyzable GxP audit data resulting from onsite inspections in the pharmaceutical supply chain.
Through its service plans, pharma companies benefit from access to the largest repository of audit data by purchasing audit credits, which can be flexibly redeemed for audit reports, data analytics services, and software solutions – without having to commit to a specific audit standard or supplier geography.
Rather than simply performing audits, Qualifyze captures and converts proprietary raw audit data to generate unique insights into supplier compliance levels across the supply chain. Through its cloud-based platform, Qualifyze customers can access and drill down into supplier compliance information at any time across multiple sites, shaping a new way to optimize supplier risk mitigation processes in a streamlined, cost-effective manner.