abenora

Pharmacovigilance, Regulatory Affairs and Quality: EU + Switzerland, MENA, GCC, CIS, Australia, New Zealand & LATAM

Regulatory Affairs

EU + Switzerland, MENA, GCC, CIS, Australia, New Zealand & LATAM

From initial gap analysis of your dossier to submission, including maintenance of Marketing Authorization. We can review your full dossier or just update or prepare the items you request. A team with experience on the mentioned markets will be responsible and a project manager will be assigned to maintain the overview and ensure a point of contact and fluent communication.

Currently, in abenora we cover EU + Switzerland, MENA/GCC, CIS, Australia, New Zealand & LATAM

In order to give you an overview, below you can see the list of the services:

  • Centralize Procedure
  • Decentralize Procedure
  • National Procedure (EU, MENA/GCC, CIS, Australia, New Zealand, Norway, Switzerland & LATAM)
  • Variations and Renewals
  • Gap Analysis
  • eCTD Publishing
  • Nees/CTD to eCTD
  • Submission to Agency and follow ups until approval
  • Maintaining dossier
  • Regulatory Support
  • Regulatory Intelligence

– Module 1 preparation, including:

  • Cover letter Application form (eAF) Artwork and Braille
  • Consultation with Target Patient Groups (Readability Testing in all EU languages) Focus Test and Bridging Reports
  • Artwork & Braille
  • Preparation of Mockups
  • Translations of labelling and mockups to oficial languages of countries mentioned
  • PSMF (Pharmacovigilance System Master File)
  • RMP (Risk Management Plan)
  • Environmental Risk Assessment
  • CPP (Certificate of Pharmaceutical Product)

– Module 2 preparation:

  • 2.4 Nonclinical Overview
  • 2.5 Clinical Overview
  • 2.6 Nonclinical Summary
  • 2.7 Clinical Summary

– Module 4

  • Search of articles related to your product to support Module 2

– Module 5

  • Search of articles related to your product to support Module 2

Regulatory Affairs: Readability Test – Consultation with Target Patients Groups

Abenora can perform readability test, focus test, bridging reports and statements. You can contact us for a free consultation to decide which strategy fits your case.

The team has performed hundreds of tests and have a network of interviewers that ensure that we can currently cover all countries and languages in Europe.

If you are interested in further information, get in contact at info@abenora.com

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