Carla Landolfi Interview
ToxHub is a leading toxicology consultancy dedicated to helping businesses navigate complex global regulatory requirements while ensuring product safety and innovation. Founded by an industry expert with over 25 years of experience, ToxHub provides science-driven, tailored risk assessments that streamline regulatory approvals across pharmaceuticals, medical devices, and consumer products. By leveraging cutting-edge in vitro and in silico methods, the company reduces reliance on animal testing while enhancing accuracy and efficiency. With a strong focus on continuous learning and regulatory compliance, ToxHub empowers businesses with practical, actionable solutions for safer and faster market entry.
The Vision Behind ToxHub
We started the interview by asking, “What inspired you to establish ToxHub, and what makes it unique in the industry?”
Carla Landolfi replied, “After spending over 25 years in toxicology, including managing a toxicology group in the pharmaceutical industry, I saw a growing need for specialized regulatory and safety expertise. Many companies struggle not only with complex global toxicology regulations but also with ensuring product safety in a way that is both efficient and cost-effective.
That’s why I founded ToxHub—to provide science-driven, tailored toxicological risk assessments that help businesses overcome regulatory hurdles while maintaining innovation and speed to market. For years, I was the one seeking consultants to help navigate complex safety regulations, so I understand first-hand what businesses need—and what they often don’t get—from external experts.
Our goal is to provide practical, science-driven solutions that not only ensure compliance with global standards like ICH, EMA, FDA, and ISO but also streamline product development and speed up market entry. Since joining the SenzaGen Group in 2022, we’ve expanded our expertise to cutting-edge in vitro and in silico methods, helping companies reduce animal testing while improving the accuracy and efficiency of safety assessments.
Having seen both worlds, I know how to deliver consultancy that truly supports businesses—offering not just expertise but real, actionable solutions.”
Navigating Regulatory Complexities
The Worlds Times: What are the biggest challenges companies face in obtaining regulatory approval, and how does ToxHub help overcome them?
Carla Landolfi replied, “Regulatory approvals can be a minefield, especially in highly regulated industries like pharmaceuticals, medical devices, and cosmetics. Companies must meet stringent global standards, and one of the biggest challenges is toxicological risk assessment —identifying and mitigating safety concerns before submission.
At ToxHub, we take the guesswork out of the process. We support businesses with everything from non-clinical study design to impurity evaluation, extractables and leachables assessments, and occupational and environmental risk evaluations. Our tailored, science-backed strategies help companies avoid common regulatory pitfalls, optimize their safety data, and accelerate approvals. By staying ahead of ever-changing regulations, we empower our clients to launch safe, compliant products efficiently and with confidence.”
Keeping Professionals Ahead in Toxicology
The Worlds Times: Continuous learning is critical in toxicology. How does ToxHub help professionals stay up to date?
Carla Landolfi replied, “Toxicology is a constantly evolving field, with new research, regulations, and technologies emerging constantly. Staying updated is crucial for professionals working in pharmaceuticals, chemicals, medical devices, and consumer products. That’s why at ToxHub, we not only provide customized training programs tailored to the needs of individuals and organizations, but we also make sure our own team stays at the forefront of the industry.
Our experts actively participate in symposiums, training courses, and international conferences to stay up to date with the latest advancements in toxicology, regulatory science, and alternative testing methods. This commitment to continuous education ensures that we offer our clients the most current and scientifically sound advice. In consultancy, having a knowledgeable team makes all the difference—regulatory requirements are complex, and only a well-informed, up-to-date expert can provide the right guidance.
Unlike generic training programs, our courses combine deep scientific knowledge with real-world case studies, equipping participants with practical skills they can apply immediately. We cover key areas like regulatory toxicology, risk assessment and impurity evaluation. With a team that is constantly learning and evolving, we empower professionals to stay compliant, make informed safety decisions, and adapt quickly to new regulations. In a field where scientific advancements directly impact human health, continuous education isn’t just valuable—it’s essential for success.”
Emerging Trends in Toxicology
Lastly we asked, “What trends are shaping the future of toxicological risk assessment?”
“Toxicology is evolving rapidly, driven by advancements in AI, computational modeling, and personalized safety assessments. One of the biggest trends is the rise of in silico methods—computer-based toxicology models that analyze vast datasets to predict biological interactions more accurately and efficiently than animal tests. Regulators worldwide are also pushing for more sustainable, non-animal testing approaches, increasing the adoption of in vitro models. At ToxHub, we integrate these cutting-edge innovations into our toxicological evaluations, ensuring our clients stay ahead of industry changes. The future of toxicology is smarter, faster, and more human-relevant —and we’re proud to be driving that change.” Carla Landolfi Concluded
Connect with Carla Landolfi on LinkedIn
Visit ToxHub to learn more about it
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