TOX-RSA assists manufacturers of small molecule pharmaceuticals, biologics, medical devices, and combination products (drug-devices and biologic-devices) in regulatory-driven pharmacology, toxicology, neurotoxicology, and other nonclinical areas.
- Development of strategic nonclinical testing plans (from early stage preclinical discovery through clinical development and post-approval)
- Interpretation and critical analysis of nonclinical data
- Data gap analysis, mock FDA reviews of draft submissions, identification of vulnerabilities
- Trouble shooting and development of effective, practical solutions
- Development, implementation, and management of strategic nonclinical testing programs, including individual study protocol development and study management
- Clinical dose selection based on nonclinical data
- Preparation of manuscripts, white papers, and expert reports
- Review and integration of the scientific literature
- Nonclinical report and summary preparations
- Preparation of regulatory submissions (pre-INDs, INDs, exploratory INDs, NDAs, BLAs, IDEs, CTDs, eCTDs, 510ks)
- Preparation of responses to FDA communications
- Development of in-house and testing laboratory Standard Operating Procedures
- Placement of nonclinical studies and study monitoring
- Staff training
- Auditing for data integrity and compliance with Good Laboratory Practice regulations (21CFR Part 58)
- Due diligence evaluations for possible acquisitions and investments
- Risk assessment