Document Management

Complete characterization of mesenchymal vesicle isolation and QC results including particle size, morphology, and surface marker analysis.

Step-by-step LNP-siRNA preparation and quality control procedure including reagent specifications and acceptance criteria.

Draft submission for FDA pre-IND meeting request including product characterization data and initial toxicology summary.

Draft protocol for GLP toxicology and safety pharmacology studies including dose selection rationale and study design.

Initial draft of Investigational New Drug application covering CMC, nonclinical, and clinical sections.

Clinical investigator brochure for OrganShield therapeutic candidate including preclinical data summary and safety information.