ToxHub Srl

ToxHub is your partner in toxicological risk assessment, dedicated to advancing the safety of drugs, medical devices, biocides, and cosmetics. With a robust foundation in science and a commitment to innovation, we offer comprehensive services tailored to navigate today's regulatory complexities and tomorrow's safety challenges. Pharmaceuticals & Biotech: we specialize in small and large-molecule toxicology programs. Our team possesses deep expertise in the safety assessment of large molecules, including antibodies, vaccines, and gene therapies. We can support you in impurity qualification, including nitrosamines from the initial risk assessment to the Acceptable Intake definition. Medical Devices: leverage our expertise in biocompatibility evaluation from the plan to the final biological evaluation to affirm your devices' safety, efficacy, and regulatory compliance. Cosmetics: thanks to our experts, we can provide you with robust Product Information Files for your cosmetics. We can assist you with MoCRA for the USA market. Medical writing: expert medical writing services for clear, compliant documentation. Specializing in clinical research, regulatory submissions, and scientific publications. Why Choose ToxHub? We offer comprehensive safety assessments, regulatory compliance services, and innovative solutions to ensure global safety standards. Our approach integrates scientific rigor with strategic regulatory insights, supporting clients from concept to commercialization. Our multidisciplinary team brings together the best in toxicology, biotechnology, and scientific research. Innovative Approaches: We integrate cutting-edge technologies to deliver precise, ethical, and efficient risk assessments. Navigating the regulatory landscape can be daunting. We provide expert guidance to ensure your products comply with international standards, including FDA, EMA, and ISO regulations.