Preclinical Drug Development Services

VERITOX® provides drug development expertise in toxicology and ADME. We design, implement, and oversee preclinical IND-enabling toxicology programs and support development programs from early lead optimization through Phase 3 and registration.

Our preclinical specialist has worked with a wide range of therapeutic products and has substantial experience providing support for ADME and efficacy work associated with small molecule and biologic-based drug development.

In addition, we have significant expertise in evaluating drug development opportunities for licensing and partnering activities such as acquisition or out-licensing.

Preclinical Studies

We design and monitor non-GLP and GLP preclinical studies:

• General toxicology (acute and repeated dose)
• Carcinogenicity
• Reproductive toxicology and teratology
• Genetic toxicology
• Safety pharmacology
• General pharmacology and efficacy studies
• ADME (pharmacokinetics/metabolism/QWBA)
• Immunotoxicology

Regulatory Submissions

We prepare toxicology and nonclinical summaries for regulatory submissions in CTD format for a range of needs:

• Investigational New Drugs
• Biological License Applications
• IND Annual Reports
• Investigator's Brochures

Specialty Services

We provide specialty services tailored to clients needs:

• Write technical or white papers
• Conduct due diligence assessments
• Prepare and review of standard operating procedures
• Conduct peer review
• Perform GLP facility audits
• Monitor FDA GLP, EMEA, MHLW, and ICH guideline compliance
• Support litigation

For further information please contact Eric W. Austin, PhD, DABT