Technical Documentation

Due Diligence Project and Solution, from digitalization to Base-Line e-CTD

Due Diligence and eCTD Base Line Creation;

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Digitization of paper technical dossiers;

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CTD / NeeS / eCTD drafting from analytical and / or productive documentation;

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Updating and management of electronic documentation from NTA to CTD/NeeS/eCTD;

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Preparation, integration and sending of sections for New Applications, Responses, Variations and Renewals;

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eCTD Modules Submission EU/CESP – GCC/SFDA/SDR – FDA/ESG.

OP Pharma integrates the services listed above with e-Dox