Services
Toxicology Support
Regulatory Toxicology Strategy Development
We offer full-service regulatory and product development consulting services for drugs and biologics, combination products. We can review existing development plans (gap analysis) and provide guidance where needed. We also assist clients with regulatory agency interactions
Literature Review And Regulatory Submission Preparation
Conduct literature review and writing. Preparation of nonclinical sections of INDs and NDAs using Common Technical Document (CTD) format for regulatory filings (e.g., FDA, EMA, Health Canada). Prepare Investigator’s Brochures. Interact with regulatory agencies.
Study Design and Monitoring
For clients in the study execution stage, we design studies, monitor at CROs and analyze data as needed. Our scope of services includes IND enabling toxicology studies and supporting for all activities such as pharmacokinetics, ADME, genetic and safety pharmacology programs.
Toxicology Risk Assessment for Medical Devices
We specialize in information gathering and evaluation of associated extractables or leachable in medical devices identified during chemical characterization or based on the composition of the materials of construction to characterize biological and toxicological risks that can compromise patient safety