Scientists at CanBioPharma Consulting have a proven track record of interactions with regulatory agencies.
We assist clients in pre-IND/CTA and pre-NDA/NDS meetings with regulatory agencies. We also participate as members of expert panels that have provided independent third party opinions to regulatory agencies regarding safety assessment of novel therapeutic agents. We provide lucid, concise, relevant safety information with high standards of integrity.
Regulatory agencies frequently seek our independent opinion and perspective related to the relevance and significance of findings in nonclinical studies.
Our team prepares nonclinical components of regulatory documents - IND/CTA, NDA/NDS, Product Monograph, Investigator's Brochure, and other written communications with regulatory agencies relative to safety concerns. We provide clear, accurate, balanced summary documents.
