OP Pharma

Regulatory Affairs Outsourcing and Consulting

Young and dynamic society

Dr. Osvaldo Ponchiroli

Performance, Services, Digital Regulatory

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Technical Documentation

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

Due Diligence and eCTD Base Line Creation;

Digitization of paper technical dossiers;

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

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

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

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

OP Pharma integrates the services listed above with e-Dox

All the services

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