Services
- Preclinical development plan for new chemical or biological entities
- Fast track program for first in human
- Design and implementation of toxicology studies including metabolism & toxicokinetics
- Genetic Toxicology program and implementation
- Safety pharmacology studies according to ICH 7a &7b
- Reproductive Toxicology (segments I, II and III)
- Juvenile Animal studies for pediatric clinical investigation
- Study monitoring in the CROs and interface with Study Directors and sponsor
- Assessment and review of toxicity reports
- Contribution to Investigator’s Brochure and Investigational Medicinal Product Dossier (IMPD)
- Preparation of non-clinical overview (2.4 of the CTD dossier)
- Review of module 2.6 of Common Technical Document (pharmacology, toxicology and pharmacokinetics)
- Safety/Risk assessment of preclinical data including calculation of human safety factor
- Safety/Risk assessment of impurities in drug substance or in drug products
- Pathology peer review in-house or by CROs including carcinogenicity studies
- Perform study pathology in-site by clients or by CROs
- Liaison with Regulatory Agencies
- Non-clinical support for the clinical development. Translational medicine.
- Preclinical support for mature products or for new drug formulations
- Due diligence of preclinical dossiers for licensing-in or out new products