"We always found solutions to problems and were able to be proactive in anticipating the need for solutions." Senior Director Regulatory Affairs, Biotech Company
Nonclinical
Our Nonclinical support provides Nonclinical consulting to ensure successful Nonclinical compliance and submissions to all worldwide regulatory agencies. Our consulting support includes:
Preparation of Pharmacology and Toxicology sections for regulatory submissions
Pharmacology and Toxicology program review and development
Gap Assessment of current Nonclinical programs
Identification of Nonclinical testing laboratories
GLP inspections
Provide support in development and submission of nonclinical regulatory documentation required for national and international dossiers
