Regulatory Support

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OUR SERVICES

Regulatory
Support

Dossier Preparation and Technical Review
Consultation & Suggestion
Highly Skilled CMC Professional Team

Prestige Biologics As a common international format for drug approval related to drug quality,
it is documented and verified that R&D and manufacturing processes related to the quality
of drugs (DS, DP) are consistently controlled and managed during the drug development process.

CTD Triangle

Module 1(Not part of the CTD)-Regional administrative information/ Maodule2(The CTD)-Quality overall summart, Non-clinical overview, Non-clinical summary, Clinical overview, Clinical summary/ Module3(The CTD)-Quality/ Module4(The CTD)-Non-Clinical study reports/ Module5(The CTD)-Clinical study reports

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The CTD triangle. The Common Technical Document is organized into five modules.
Module 1 is region specific and modules 2,3,4 and 5 are intended to be common for all regions.

eCTD

Module1
Administrative information and prescribing information
Module2
Common technical document summaries
Module3
Quality
Module4
Non-clinical study reports
Module5
Clinical study reports