title: The role of QC/QA in "paper" NDA submissions.
authors.affiliation: Pharmaco LSR, Incorporated, 4009 Banister Lane, Austin, Texas 78704, USA.
authors.forename: R D
authors.initials: RD
authors.lastname: Heilman
authors.forename: L
authors.initials: L
authors.lastname: Jones
authors.forename: L V
authors.initials: LV
authors.lastname: Kapili
authors.forename: G
authors.initials: G
authors.lastname: Zamora
mesh_terms: D004282:Documentation; D017387:Investigational New Drug Application / Q000458:organization & administration*; D009936:Organizational Innovation; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D012107:Research Design; D013997:Time Factors; D014481:United States