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Ectd

Found 5 free book(s)
ICH M2 EWG - ESTRI

ICH M2 EWG - ESTRI

estri.ich.org

ich ectd specification v 3.2. 2 16-july-2008 international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use

  Specification, Ectd specification, Ectd

EU Module 1 eCTD Specification - Europa

EU Module 1 eCTD Specification - Europa

esubmission.ema.europa.eu

2 Document Control Change Record Version Date Author(s) Comments 0.1 July, 2001 Stan van Belkum Draft 0.2 September, 2001 Stan van Belkum Draft

  Specification, Module, Ectd, Eu module 1 ectd specification

CTD: Revisions to the M4 Granularity Document

CTD: Revisions to the M4 Granularity Document

www.ich.org

1/23/2017 7 13 Table 2: Module 3 (paper & eCTD v3.2.2) • R3 Revision (2004) o P.4 Control of Excipients documents, can be rolled-up into a single P.4 document, but still may be submitted at the lower P.4.x level if needed • R4 Revision (2016) o P.4.x documents can be rolled-up into a single P.4 document

  Ectd

eCTD Guidance Document - Europa

eCTD Guidance Document - Europa

esubmission.ema.europa.eu

This guidance document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic Common Technical Document format (eCTD) to the National Competent Authorities

  Document, Guidance, Ectd, Ectd guidance document

60 TTIIPPSS ETTOO BBECCOOMMEE A GOOODD ...

60 TTIIPPSS ETTOO BBECCOOMMEE A GOOODD ...

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