|
Nonclinical and preclinical pharmacology and toxicology services offered by the BioPharm Team include:
- Strategic design of nonclinical safety programs (safety pharmacology, toxicology and toxicokinetics) to support regulatory filings
- Assistance with protocol development for nonclinical safety studies
- Managing of outsourced nonclinical safety programs (obtaining time and cost estimates, placing and monitoring of the studies, acting as the Sponsor’s representative during conduct of the studies, critiquing the draft final reports and maintaining the project timelines)
- Writing of nonclinical toxicology, toxicokinetic and safety pharmacology portions of regulatory submissions (e.g., INDs, NDAs, and CTDs)
- Assistance with addressing questions from regulatory authorities regarding nonclinical and preclinical safety issues
BioPharm Team consultants who offer these services:
Kathleen Baran, PhD, DABT
Shehnaz Gangjee, PhD
|
|
