PreclinXP: Preclinical EXperts Pharmacology Toxicology
- Consultancy to plan and speed-up drug development from regulatory approach to in-person meetings with Health Authorities.
- Nonclinical advice for GLP and non-GLP Pharmacology and Toxicology.
- CRO selection for cost-effectiveness and study planning / monitoring.
- Review of preclinical documentation (study protocols, reports, IND, CTD).
- Expert Opinion on single issues.
Thanks to personal relationships and collaborations with Italian / Foreign companies and Universities , as well as with trusted Professionals with decades of experience in R&D, an impressive amount of expertise is available to ease your way to First-In-Man and Marketing Authorization. Proof of concept can take advantage from innovative investigational techniques, and safety requests are more and more demanding. In addition, questions from regulatory bodies may request a re-evaluation of the existing documentation by an expert “independent eye”