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Dossier Lifecycle Management
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Pre-submission facility correspondence of ANDA
Annual Report (AR)
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Periodic Adverse Drug Experience Report (PADER)
Change Being Effect-0 (CBE-0)/Change Being Effect-30 (CBE-30) and US Prior Approval Supplement (PAS)
Amendment/MoHs Query Response (Day 0, 70, 100, 105, 106, 120 etc.)
Variation Type IAIN, IA, IB, II
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Medical Devices
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AFFORDABLE CARE ACT (ACA)-6004
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QSAR
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WHO Prequalification
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