Comprehensive Dossier Preparation
Patrick assists clients on best regulatory pathways and compiles detailed preclinical dossiers covering safety pharmacology, genetic toxicology and animal toxicology data, and other essential elements for regulatory submissions to health authorities.
Patrick prepares nonclinical safety sections for IB, PreIND & IND, IMPD & CTA, sections 2.4 and 2.6 of CTDs, BLAs, NDAs, & MAAs.
Seamless Product Development
Accurate documentation and regulatory support are vital for effective product development. Patrick ensures that all preclinical documentation is prepared accurately and thoroughly.
