In-house Dossier Development Facility
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Dossier Services for more than 85 countries
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PSUR -Periodic Safety Update Reports
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Ready CTD / ASEAN CTD dossiers
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Free consultation: - pre-product registration / pre-dossier preparation inquiries
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Analytical Method Validation (Formulation and API)
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Special reduced charges for Pharmaceutical SMEs and small manufacturer
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Regulatory training for Industries and Academic
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Dossier conversion (from one country to another)
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Ready dossier available for Asian, African and CIS market (CTD or Non-CTD dossier)
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Dossiers as per ASEAN CTD Guideline
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Dossier in EUCTD format
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Dossier as per latest regulatory guidelines (released by MOH)
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Dossier Preparation: - Africa, Asia, CIS, Europe, Central America, North America, South America
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Stability Studies - Real time and Accelerated stability studies
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Process validation
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Complete regulatory assistance till the registration stage
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Pharmaceutical Technology - Know How
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Assistance for Product Development
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SmPC, Pack insert and PIL preparation
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Clinical and Non-clinical Overviews and Expert Report
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EUCTD and ASEAN CTD dossiers compilation and review
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Dossier Developing Unit
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Patent Cell
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Bioequivalence Studies
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Animal Toxicological Studies
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Professional Training for corporate top management, industrial staff and college students
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European-CTD / ICH - CTD Dossier Compilation for regulated market