We provide consultancy services to our clients involved in pre-clinical studies to help them comply with the FDA regulations including:

• compliance with GLP regulations (Good Laboratory Practices).

• safety and toxicity in animal models,

• data integrity and comprehensive study documentation.

When needed, we work with the study team to analyze the data and prepare it for public presentations and peer review publications.

We provide services to help the study team properly prepare the data in eCBT format for IND (Investigational New Drug) and BLA (Biologics License Application) submissions.