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”

email to:

alberto.morisetti@preclinxp.it