Services: Preclinical

Applying extensive experience and understanding of preclinical drug development, PPD designs and implements strategies and programs to provide information about the pharmaceutical composition of a new drug, its safety, how the drug will be formulated and how it will be administered to the first humans. Using previous data about the compound, we help you develop an effective regulatory strategy for GLP toxiocology and metabolism studies required to support first-in-man studies. Our proactive, integrated approach helps align preclinical testing with your longer-term drug development goals.

Strategic Development
Coordinated development programs bridge early compound development to clinical trials.

Preclinical Evaluation
The highly responsive, expert staff at Piedmont Research Center (PRC), a division of PPD, provides a full spectrum of in vivo and in vitro research services.

Chemistry, Manufacturing and Controls Consulting
Chemistry, manufacturing and controls (CMC) programs are fully integrated with clinical and regulatory plans.

Pharmacology and Toxicology Consulting
Scientific expertise in a regulatory context support tailored preclinical plans.

Regulatory Submission
Effective regulatory assessment and strategy guide your product’s development.