We provide cost effective, quality preclinical CRO services. At no additional fee, we will design and optimize a GLP toxicology study plan to meet FDA requirements for your particular indication.
Our decades of experience in the preclinical industry provides our clients with important insight into developing plan of execution for your GLP toxicology studies required for IND submission. We also have experience designing and optimizing GLP toxicology and safety pharmacology studies for your particular indication. We also have experience in designing programs to meet aggressive timelines (although this generally increases program costs). We provide guidance to navigate the FDA process required for an IND-enabling program to ensure the correct toxicology studies are conducting to obtain IND approval.
Discovery / non-GLP Toxicology Studies
Pharmacokinetics Study (PK)
Maximum Tolerated Dose Studies (MTD)
Dose Range Finding Study (DRF)
hERG - Ion Channel Screening
Exploratory Toxicology Study (usual combined with a PK or DRF study)
Toxicology Studies (GLP or non-GLP)
7-day Repeat Dose Study (GLP or non-GLP)
14-day Repeat Dose Study (GLP or non-GLP)
21-day Repeat Dose Study (GLP or non-GLP)
3-month Chronic Repeat Dose Study (GLP or non-GLP)
6-month Chronic Repeat Dose Study (GLP or non-GLP)
9-month Chronic Repeat Dose Study (GLP or non-GLP)
Safety Pharmacology Studies
Cardiovascular Study (Telemetry or Piggy-backed)
Central Nervous System Study (CNS Study)
Genetic Toxicology (Genetox)
All typical drug development rodent and non-rodent species offered
All typical routines of administration offered (including infusion)
We develop a GLP toxicology and safety pharmocology strategy based on your molecule, the type of indication and an initial gap analysis of the data from the studies already completed.
Then, we help you generate a road map of milestones in the PROPER order to create an efficient path through GLP toxicology and safety pharmacology studies. This strategic plan includes categories of milestones which enable the full IND-enabling program to be segmented into manageable pieces (from both a study execution standpoint and financial outlay). Our experience will provide you with a GLP toxicology and safety pharmacology study programs that satisfies FDA requirements while minimizing unnecessary costs. Time is generally saved as a result of a more efficient program.
For time sensitive toxicology programs, we design a study plan and strategy that will expedite your time to completion for your GLP toxicology studies and other safety related studies required for your drug's indication.
Call for a consultation 202-780-4988