The expert team.
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.
Ughetta del Balzo, PhD
Senior Research and Development Consultant
Expert in Non-Clinical Safety and Efficacy in Drug Development
Ughetta is an experienced leader with over 25 years in the biotech industry, specializing in the development of both small and large molecule drugs and devices. She has extensive experience building and leading R&D programs in global biotech companies in the US and possesses a deep understanding of preclinical development and regulatory filings (FDA, EMA, CFDA).
Areas of expertise
- Drug Discovery and Development: Specializing in preclinical development of small molecules and Peptides targeting cardiovascular diseases, inflammation, anemia, fibrotic diseases, and cancer.
- Toxicology and Safety Pharmacology: Safety and efficacy programs, e.g. PK/ADME studies.
- Regulatory Affairs: Managing regulatory submissions for INDs, IDEs, NDAs, BLAs, and PMAs, creating non-clinical packages for global regulatory submissions, such as DSURs, CCDS, while interfacing with FDA and European authorities.
Maria Labanca
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
Junior 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.
More than just an answer
Personalized guidance and close dialogue.
Support through the entire regulatory process.
Profound knowledge in both toxicology and pharmacology.
