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FDA Compliance Assessments & Assistance |
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CTD Filings and amendments for all the regulatory authorities including US, Europe, Canada, Australia and any other |
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Evaluation of pharmaceutical regulatory documents and
systems. |
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Preparing Expert reports on regulatory documents. |
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Review drafts of CTDs against the requirements. |
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Preparing Tech packs/Technical dossiers as per the
customer requirements. |
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Support in regulatory document registration in various
countries across the world. |
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Comprehensive regulatory support. |
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Preparation of Process Development Reports |
