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US Drug Master File
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US OTC Monograph Registration
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Dossier Lifecycle Management
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Proprietary Name Request
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Information Request (IR)
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Complete Response (CR)
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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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Response to Telephone Request and e-mail Request
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Act as a Plant representative during Regulatory Inspections
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Audit
Regulatory Compliance Audit
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Pre-Health Authorities Mock Audit
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Quality Systems Development
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Merger and Acquisition Consulting Services
GMP Retainership on Hourly Basis
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Labeling & Artwork
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USFDA SPL and Health Canada SPM
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eCTD Publishing & Submission
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Submission Dispatch and Archival
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PV System Setup and Audit
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Global Monitoring and Literature Search
Aggregate Reporting (PADER/PSUR)
Associate Regulatory Services
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
Global Language Translation Assistance
EU MAH and QP Services Assistance
Pharma Software
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Industries We Support
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/ Industries We Support
Innovator Companies
Generic Companies
Biologics Companies
Biosimilars Companies
CRO (Clinical Research Organization)
CDMO (Contract Development and Manufacturing Organization)
CMO (Contract Manufacturing Organization)
Raw Material & Intermediates
API (Active Pharmaceutical Ingredients)
Pharma Research & Development (R&D)
Excipients
Formulation (Drug/Biologics)
Packaging Materials
Medical Devices
Analytical Labs
OTC (Over the Counter)
Cosmetics
Nutraceutical
Food/Dietary Supplement
Veterinary
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