Levine Tox Consulting can:

• Stretigic Planning
• Design nonclinical drug development programs for a variety of drug classes.
• Provide support for all phases of nonclinical drug development activities including toxicology, pharmacokinetics, ADME, and safety pharmacology programs.
• Establish and manage all interactions with contract research organizations (CROs) including:
• Proposal generation
• CRO selection
• Auditing
• Contract set-up
• Study design
• Study monitoring
• Report review
• Prepare nonclinical sections of:
  • INDs, NDAs, etc., in Common Technical Document (CTD) format                                                             for regulatory filings (e.g., FDA, EMA, Health Canada).
  • Investigator’s Brochures
• Interact with regulatory agencies.
• Qualify impurities in drug substances and drug products.
• Provide assistance with government contracts (experience as PI).
• Provide product liability/forensic toxicology support.