Preclinical development services and consultancy

CTA enabling toxicology, PK and metabolism

Complete packages to support First Dose
In Human and formal IND/IMPD:

• Single and repeated-dose GLP safety studies in mice, rats, dogs, monkeys
• Safety pharmacology regulatory packages
• Toxicokinetic and toxicodynamic (TK/TD) assessment
• Preparation of pre-clinical regulatory documentation

Drug Disposition:

• Synthesis of radiolabeled compound
• Excretion balance and metabolism studies in all animal species
• Quantitative whole body autoradiography (QWBA)

Clinical Support Services:

• Clinical Bioanalysis
• Biomarker assays
• Clinical pharmacokinetics
• Support for special studies (human metabolism; bioequivalence; drug-drug interactions)

Preclinical consultancy and regulatory documents preparation