PreclinXP Preclinical EXperts Pharmacology Toxicology

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”

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