Other Services

We provide support with our strong academic and technical infrastructure in matters such as compliance with authority requests, resolution of technical deficiencies, and filing in international standards (CTD).

Detailed Service Areas

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TR/ENG technical document preparation

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Protocol and report preparation

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SOP (Standard Operating Procedure) preparation

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Technical support for preparing authority deficiency letters

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DMF control in compliance with CTD format

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Analytical examination of Technology Transfer files

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Dossier control in CTD format

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Documentation and filing support in compliance with regulations

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Alternative source evaluation