Preclinical Services

PPD has extensive experience and understanding of preclinical drug development.

We offer:

• Appropriate resources for any study
• Customized product development plans
• Proactive approach to help align nonclinical testing with long-term development goals

We have the knowledge, insight, flexibility and commitment to achieve our clients' objectives.

We design programs to provide information about the pharmaceutical composition of a new drug, its safety, how it will be formulated and how it will be administered to the first humans. Using previous data about the compound, we help our clients develop an effective regulatory strategy for good laboratory practice (GLP) toxiocology and metabolism studies required to support first-in-man studies.

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

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

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

Regulatory Submissions
Effective regulatory assessment and strategy guide a product's development.