Nonclinical
Toxicology
Toxicology services include the strategic planning, design, implementation, monitoring and reporting of toxicological studies. Here are some of the services Pacific BioDevelopment offers in this arena:
- Strategic development and implementation of Phase-appropriate non-clinical programs
- Development of oral and written regulatory correspondence
- Selection and oversight of laboratory resources
- Draft and/or review internal non-clinical safety reports
- Draft and/or review of non-clinical toxicology sections for regulatory submissions (U.S. and International)
- Due diligence for in-license opportunities
- Prepare for and participate in FDA meetings
- Good Laboratory Practices (cGLP) and study monitor training
- Provide interim management and oversight for clients without internal staff
