The role of QC/QA in "paper" NDA submissions.
Heilman
R D
RD
Pharmaco LSR, Incorporated, 4009 Banister Lane, Austin, Texas 78704, USA.
Jones
L
L
Kapili
L V
LV
Zamora
G
G
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