Download Our Repeat Use Procedure Slide Deck

The issue of Repeat Use Procedures generates many questions to our pharmaceutical regulatory affairs team.  We have created a slide deck looking at the main points to consider when completing a Repeat Sue Procedure.  You can download it below.

The Repeat Use Procedure slide deck looks at:

• What is a Repeat Use Procedure?
• Steps to consider
• What should be included in the dossier?

You can download the Repeat Use Procedure slide deck by completing the form below.  Don’t forget to subscribe to our newsletter to stay up to date on the latest whitepapers, blogs, slide decks, and more from Acorn Regulatory. [ninja_form id=87]

Further Reading

CMC & Pharmaceutical Regulatory Affairs Services

Our pharmaceutical regulatory affairs team is staffed by experts who have considerable expertise in the sector.  Every team member has at least 15 years of  experience in the pharmaceutical sector assisting pharmaceutical companies with their regulatory issues.  Since 2002, our pharmaceutical regulatory affairs specialists have been working with clients all over the world. Read more about our team here.

Can You Use A U.S. Dossier To Apply For A European Marketing Authorisation?

Is it possible to use a U.S. dossier when applying for an E.U. marketing authorisation?  This is a question that is asked time and again.  We first published this article in 2017.  Below, we have updated it and included links to other relevant articles that will assist companies dealing with this issue. Read the article here.

Marketing Authorisation Holders – An Overview

Acorn Regulatory’s consultants are experts in the sector.    Members of our team have written extensively on this website and in other industry publications about the issues associated with marketing authorisations holders and much more.  Below we have highlighted just four articles that our team members have written on the subject in recent times. Read the full article about Marketing Authorisation Holders here.

Need A WDA? Read Our Step By Step Guide

There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years.  We have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining a WDA.  Read the full article here.

How To Prepare For A Pharmacovigilance Inspection

A pharmacovigilance inspection can be a daunting prospect for many companies.  Since 2002 we have worked with countless companies to guide them through their inspections. We look at the measures that your company can take to be prepared.  Read the full article here.

How To Complete A Type I Variation

Type I Variations to a Marketing Authorisation are surprisingly difficult.  The procedure that many people perceive to be a simple process can prove to be otherwise.  This article looks at how to complete a type 1 variation and we will consider:

• common deficiencies
• common validation issues
• the challenges posed by the eAF
• what to do when documentation is missing
• how to handle GMP variations
• what happens when a CEP is presented for an active substance instead of a GMP certificate

After reading this article you will be better placed to complete a Type I Variation to a Marketing Authorisation while avoiding the common pitfalls outlined below.  Read the full article here.

What Are The Initial Steps in Applying for a Marketing Authorisation?

We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA).  In this article, we aim to provide a guide to assist companies applying for an MA We have also provided a number of links throughout the article to relevant articles, authorities, organisations, and pieces of legislation to assist you.  Read the full article here.