Scientists at CanBioPharma Consulting) have a proven track record in the provision of independent expert opinions regarding the relevance and significance of findings in nonclinical studies of therapeutic candidates (new chemical entities and biologics).
We have provided expert opinions in the form of independent written "white-paper" reports, in face-to-face meetings with regulatory agencies, in written summary reports and as members of expert panels. The written expert reports have been submitted to the Therapeutic Products Directorate (TPD), Health Canada; the US FDA, and to numerous regulatory agencies globally.
CanBioPharma Consulting expert opinions have contributed to:
Pivotal decisions regarding continued development of drug candidates including: Go / No-Go decisions; and key judgments related to human safety (e.g. dose levels and tools for monitoring potential toxicity in clinical trials)
Scientific/regulatory issue resolution. Our problem solving has enabled approval of INDs/CTAs, lifting of clinical holds, and contributed to NDS / NDA approval
Priority review of NDS - our input and presentations as members of Expert Panels has enabled granting of priority review of NDSs by TPD
NDS approval - Our expert input provided to private companies or directly to regulatory agencies has influenced drug approval decisions
