Over 15 years of experience in R&D, regulatory, quality assurance and compliance. Strength lies in GLP, QC, QA, pre-IND, IND, CTA , BLA, 510 (k) submissions, compliance, training and auditing, grant, manuscript, SOPs and technical report writing. Specialties:- Gene therapy, gene editing, rare disease, obesity, metabolic disorders, CNS disorders, virology, hematology, metabolic disorders, oncology, in vitro diagnostics (IVDs), medical devices.