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Dossier Lifecycle Management
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Pre-submission facility correspondence of ANDA
Annual Report (AR)
Product Correspondence
Promotional Labeling Advertising (OPDP - Ad-Promo)
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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Transfer of a Marketing Authorization
Periodic Safety Update Report (PSUR)
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Priority Review Request
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Merger and Acquisition Consulting Services
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USFDA SPL and Health Canada SPM
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PV System Setup and Audit
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US Agent and Other Regulatory Services
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Application Number Assignment
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PDE, OEL & OEB Value Reports by Toxicologists Assistance
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EU MAH and QP Services Assistance
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