Galileo Research s.r.l.
Galileo Research is a non-clinical Contract Research Organization (CRO) established in 2011 as a spin-off of Abiogen Pharma, with origins dating back to 1972 as the Research Centre of Istituto Gentili. It provides expertise, knowledge, and skills to accelerate the development and market entry of drugs, medical devices, food supplements, and cosmetics, ensuring compliance with global regulatory requirements. The organization has a rich history of discovering and developing molecules in the field of bone diseases, oncology, and CNS, and offers a broad range of non-clinical studies, including toxicology, biocompatibility, efficacy, and mechanisms of action. Galileo Research is committed to quality, as evidenced by its ISO 9001 certification, and emphasizes animal welfare and the 3Rs (Reduction, Refinement, Replacement) in its research practices.
Industries
Nr. of Employees
small (1-50)
Galileo Research s.r.l.
Migliarino Pisano, Toscana, Italy, Europe
Products
Medical Devices Testing Services
Tailored non-clinical development strategies, precision-driven testing, biological evaluation plans (BEP), and comprehensive biological evaluation reports (BER) in compliance with ISO 10993-1, OECD standards, and GLP.
Novel Foods, Dietary Supplements and Botanicals Testing and Validation Services
Comprehensive safety evaluation, health benefit assessment, and regulatory toxicological data collection services for novel foods, dietary supplements, and botanicals supporting EFSA and EU compliance.
Medical Devices Testing Services
Tailored non-clinical development strategies, precision-driven testing, biological evaluation plans (BEP), and comprehensive biological evaluation reports (BER) in compliance with ISO 10993-1, OECD standards, and GLP.
Novel Foods, Dietary Supplements and Botanicals Testing and Validation Services
Comprehensive safety evaluation, health benefit assessment, and regulatory toxicological data collection services for novel foods, dietary supplements, and botanicals supporting EFSA and EU compliance.
Services
Support for lead candidate selection and execution of GLP-compliant non-clinical studies (small molecules, biopharmaceuticals, ATMPs) to support regulatory pathways.
Review and evaluation of existing safety data and performance of additional biological tests required to assess biocompatibility and product safety.
In vitro testing services for cosmetic products including dermal/ocular irritation and corrosion, dermal sensitization, genotoxicity (Ames), skin absorption, and mechanistic assays for anti-aging and whitening claims.
Design and validation of in vitro and in vivo experimental methodologies and GLP-compliant non-clinical toxicity studies to assess the safety of food products and dietary supplements.
Support for lead candidate selection and execution of GLP-compliant non-clinical studies (small molecules, biopharmaceuticals, ATMPs) to support regulatory pathways.
Review and evaluation of existing safety data and performance of additional biological tests required to assess biocompatibility and product safety.
In vitro testing services for cosmetic products including dermal/ocular irritation and corrosion, dermal sensitization, genotoxicity (Ames), skin absorption, and mechanistic assays for anti-aging and whitening claims.
Design and validation of in vitro and in vivo experimental methodologies and GLP-compliant non-clinical toxicity studies to assess the safety of food products and dietary supplements.
Expertise Areas
- Non-clinical toxicology
- Biocompatibility and medical device biological evaluation
- In vitro assay development (3D tissue models)
- Genotoxicity testing and mutagenicity assays
Key Technologies
- Good Laboratory Practice (GLP) study conduct
- ISO 9001-aligned quality management
- 3D skin and ocular tissue models
- Human Cell Line Activation Test (h-CLAT) and cell-based sensitization assays
News & Updates
The event brought together leaders from the pharmaceutical industry and regulatory affairs to discuss advancements in drug discovery, development, and evaluation, focusing on rare and complex diseases, metabolomics, AI, ADME, regulatory standards, and environmental risk assessment.
The inaugural meeting focused on medical devices, exploring scientific, regulatory, and commercial aspects, with insights from industry experts on simulations, safety evaluation, toxicological risk assessment, and innovative strategies.
Galileo Research has achieved ISO 9001 certification, reflecting its commitment to quality management, transparency, efficiency, and customer satisfaction.
The event brought together leaders from the pharmaceutical industry and regulatory affairs to discuss advancements in drug discovery, development, and evaluation, focusing on rare and complex diseases, metabolomics, AI, ADME, regulatory standards, and environmental risk assessment.
The inaugural meeting focused on medical devices, exploring scientific, regulatory, and commercial aspects, with insights from industry experts on simulations, safety evaluation, toxicological risk assessment, and innovative strategies.
Galileo Research has achieved ISO 9001 certification, reflecting its commitment to quality management, transparency, efficiency, and customer satisfaction.