The expert team.
With more than 25 years of combined experience in toxicology, pharmacology, and regulatory affairs, Our expert team offers deep, cross-functional expertise spanning the Medical Device, Pharmaceutical, Cosmetics, and Chemical industries.
Our multidisciplinary background allows us to provide tailored guidance that addresses the unique regulatory and scientific challenges of each sector. Whether you’re navigating complex EU regulations, developing a new product, or preparing for market authorization, our expert team deliver the insight and support needed to ensure safety, compliance, and success.
Carla Landolfi
Founder and CEO of ToxHub
Toxicology Risk Assessor, ERT
Areas of expertise
- Drug Development: Specializing in Preclinical studies, particularly for first-in-man trials and Paediatric Investigation Plans, and toxicological support during Due Diligence.
- Drug Manufacturing and Regulatory Compliance: Environmental Risk Assessment, Impurity Characterization, Occupational Toxicology, and Permitted Daily Exposure (PDE) evaluation.
- Medical Devices: Expertise in Biocompatibility programs, Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER).
- Cosmetics: Expertise in cosmetic safety assessment, PIF creation, and regulatory compliance.
- Regulatory Affairs: Proficient in regulatory documentation and communication, ensuring compliance with regulatory authorities.
Giorgina Mangano
Senior Scientific Consultant
Expert in Biology and Pharmacology, Certified European Pharmacologist (EuCP)
Giorgina, with over 30 years in the pharmaceutical industry, is an expert in Biology and Pharmacology and an active member of the Italian Society of Pharmacology (SIF) since 2003. She led the in vitro preclinical development team at Angelini for nine years and has extensive expertise in drug discovery, development, and regulatory frameworks, including ICH, EMA, FDA, GLP, and ISO standards, across pharmaceuticals, cosmetics, food supplements, and medical devices.
Areas of expertise
- Drug Discovery and Development: Specializing in in vitro preclinical safety programs focusing on CNS, inflammation/pain, and anti-infective therapeutic areas.
- Medical Devices: Expertise in Combination products/substance-based Medical Devices.
- Regulatory Affairs: Proficient in regulatory documentation and communication, ensuring compliance with regulatory authorities.
Maria Labianca
Regulatory Toxicologist
Cosmetic Safety Assessor, Medical Device and Consumer Products Specialist
Maria is a Cosmetic Safety Assessor certified by the Italian Society of Chemistry and Cosmetic Sciences (SICC), and offers expertise from research and development departments, focusing on the safety and regulatory compliance of medical devices and consumer products. Her background also includes managing manufacturing phases and coordinating work plans.
Areas of Expertise
- Cosmetics: Preparation of the Product Information File (PIF), CPSR (Part 2A and 2B) according to the European regulation on cosmetics 1223/2009;
- Safety assessment of cosmetic ingredients and definition of the safety profile of finished cosmetic products, including nanomaterials, fragrances, sensitizers.
- Medical Devices: Biological Evaluation Plan and Biological Evaluation Report (BEP and BER), GAP analysis according to ISO standards and MDR.
Chiara Gazerro
Regulatory Toxicologist
Specializing in Chemical Risk Assessment and Management
Chiara has expertise in producing regulatory toxicological documents, including risk assessments, PDEs and OELs. She is skilled in using in silico tools for data-poor substances, use of IUCLID dossier within REACH regulation, CLP assessment for substances and mixtures, biocidal dossier preparation. Experienced in using EUSES, ConsExpo and FOCUSPEARL models. In-depth analysis of large datasets and online literature.
Eleonora Pace
Regulatory Toxicologist
Specializing in Medical Device Safety Evaluation
Eleonora holds an MSc in Chemistry and Pharmaceutical Technology from Sapienza University of Rome, and is a qualified pharmacist. She has further strengthened her scientific and regulatory expertise through advanced postgraduate studies in preclinical and clinical drug development, covering technical-scientific, regulatory, and ethical aspects. She combines a strong research background with extensive knowledge of medical device safety evaluation.
More than just an answer
Personalized guidance and close dialogue.
Support through the entire regulatory process.
Profound knowledge in both toxicology and pharmacology.
