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eCTD/CTD/NeeS Publishing solution
  • Home
  • About us
    • Company Overview
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  • Services
    • Overview
    • Regulatory submissions
      • eCTD
      • Drug Master File (DMF)
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Blog

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Others
_ March 4, 2010_ KnetAdmin_ 0 Comments

KnowledgeNET and upcoming market trends in the EU

“From 1, April 2009, only electronic dossiers will be accepted. Paper dossiers must no longer be submitted.”

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SPL and SPL R4
_ January 20, 2010_ KnetAdmin_ 0 Comments

SPL-Prefered Substance Name

In SPL, FDA provides terminology list, which has some terms with specific codes.

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eCTD submission
_ January 2, 2010_ KnetAdmin_ 0 Comments

Electronic Submission Gateway

What is ESG (Electronic Submission Gateway)? The ESG has been setup by FDA for transfer of regulatory information in the form of eCTD, SPL, eDMF, etc.. The new Agency Gateway will enable the FDA to process regulatory information through automated mechanisms while it enables:

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eCTD submission
_ January 1, 2010_ KnetAdmin_ 0 Comments

Study Tagging Files (STF)-eCTD

Study tagging file (STF) is an xml which contains the group of files for a particular study. Study tagging files are required and applicable in US. Study tagging files applies to only module 4 and module 5 of eCTD.

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Pharmacovigilance
_ December 28, 2009_ KnetAdmin_ 0 Comments

Pharmacovigilance – ICSR submissions guidelines – updated

The EMEA has published new EudraVigilance Business Rules for exchanging Safety/Acknowledgement Messages and Individual Cases Safety Reports (ICSRs) in the EEA in line with Regulation (EC) No 726/2004, Directive 2001/83/EC as amended, Directive 2001/20/EC, Volume 9A and Volume 10 of the Rules Governing Medicinal Products in the European Union.

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Pharmacovigilance
_ November 23, 2009_ KnetAdmin_ 0 Comments

Pharmacovigilance Good Practice Guide by MHRA,UK

Pharmacovigilance Good Practice Guide by MHRA is published by Inspections and Standards Division of the MHRA which assesses pharmaceutical companies’ compliance with UK and EU legislation which relates to the monitoring of the safety of medicinal products.

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Pharmacovigilance
_ November 23, 2009_ KnetAdmin_ 0 Comments

Pharmacovigilance Explained

What is Pharmacovigilance? Pharmacovigilance (PV) is the a science relating to the detection, assessment, understanding and prevention of adverse drug reaction or events or side effects of various pharmaceuticals drugs and medicines.

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