Nonclinical Development
PPD's nonclinical development group offers pharmacology and toxicology consulting services, either à la carte or as part of a development program.
This specialized group works with clients to ensure the nonclinical program supports the intended dose, route and duration of treatment in a clinic. With guidance from the regulatory authorities, PPD's experts identify and address any pharmacology and toxicology issues unique to the compound, the indication or the patient population. The group also prepares nonclinical protocols, monitors studies, and reviews data and reports; prepares and reviews the nonclinical sections for global regulatory submissions; and provides a fast track to first-in-man studies, clinical proof of concept or marketing.
Comprehensive Consulting Services
PPD assists clients in the crafting and implementation of nonclinical pharmacology and toxicology plans. Our American Board of Toxicology-certified toxicologists communicate successfully with regulators and study monitors, and are available to provide advice on budgets, timelines and global regulatory requirements. They identify key safety and risk-benefit issues and develop gap analysis of the existing nonclinical package with assessments of strengths, weaknesses, opportunities and challenges.
Experts in Regulatory Support
By working together with the global regulatory affairs team, PPD's nonclinical development experts plan, write and review summaries of global regulatory filings, including investigational new drug (IND) applications, clinical trial authorizations (CTAs), new drug applications (NDAs), biologics license applications (BLAs) and marketing authorization applications (MAAs). They also prepare and review relevant sections for regulatory meeting packages and provide expert representation before regulatory agencies.
Cooperation across the Board
The nonclinical development group supports business development activities by leading nonclinical tasks for due diligence activities; preparing and reviewing nonclinical packages for partnering or outlicensing efforts; and representing companies that show their global programs and strategies to potential partners or outside investors.
By working together with the clinical operations, clinical pharmacology, product development and global regulatory affairs experts, the nonclinical development group is part of the entire development process. PPD responds directly to client-related issues and provides expanded services throughout the development program.
Nonclinical Development | Program Managers
