Comprehensive Non-Clinical Services
- Toxicology Testing
- ADME (Absorption Distribution Metabolism Excretion)
- Biocompatibility Studies
- Efficacy & Mechanism of Action
- Drug Re-purposing
Project Management and Regulatory Expertise
With a dedicated Project Management Team, Galileo ensures seamless execution of non-clinical testing programs to cover all aspects of development. From planning to regulatory submissions for Clinical Trial Applications (CTAs), Investigational New Drugs (INDs), and other regulatory filings under EMA, FDA, and other global authorities, we provide expert strategic guidance to ensure compliance with international standards*, including ICH, OECD, EFSA and ISO frameworks.
Our meticulous approach guarantees close to 100% regulatory submission compliance, while also enabling high-tech players in fast-developing markets to adapt effectively to new regulatory requirements, ensuring their innovation aligns with evolving global requirements.
Flagship Domains:
- Pharmaceutical GLP Toxicology Studies
- Hyaluronic acid platform
- Implanted Medical Devices (bio-polimers)
- Botanicals
- Molecular biology
- Novel food
-
3D-reconstructed human tissues in vitro
- Irritation
- Absorption
- Efficacy
- Histology
- Immunohistochemistry
Advanced Therapies
Galileo Research supports innovation in the field of advanced therapies and biotechnological products due to the pioneering experience in oncology cell therapy, now in the clinical development phase.
Key Therapeutic Areas:
- Bone and cartilage diseases
- CNS disorder
- Haematology
- Oncology
- Intestinal inflammation
- Wound healing
Digital Tools
Our state-of-the-art digital platform, including in silico and bioinformatic tools, streamlines data management and analysis of a vast amount of data generated during non-clinical studies. These technologies enable faster, more precise evaluations, reducing time-to-market while enhancing decision-making.