Strategic Development

PPD offers preclinical consulting and services that facilitate the overall clinical development strategy within domestic and global regulatory frameworks. Our preclinical experts, American Board of Toxicology-certified toxicologists and study coordinators work together to develop:

• Assessment of the existing preclinical package
• Gap analysis
• Strategic and operational efficiencies
• Preclinical development plan and timeline for successful clinical development and regulatory submissions

Services

Our services include:

• Comprehensive preclinical pharmacology and toxicology consulting
• Program development and gap analysis
• Program managers
• Identification of key preclinical, safety and risk-benefit issues
• Study design, placement, on-site monitoring and management of preclinical toxicology studies
• Review and preparation of preclinical pharmacology and toxicology sections of regulatory submissions and meeting packages
• Representation at regulatory agency meetings
• Strategic planning, writing and review of relevant sections of the investigational new drug (IND) application, common technical document (CTD), biologics license application (BLA) and new drug application (NDA) submissions

Finding the Best Services for Your Project

With our objectivity in selecting vendors to conduct the preclinical work, we provide the most appropriate resources for your study. No single vendor conducts all preclinical and toxicology testing, and most do not excel in both broad and specialized areas. Using our well-established industry network and broad base of preclinical providers, we search for and recommend the best possible resources for your project.