May 2021

Covid-19 related travel restrictions have driven many audits online. While the audit might now be conducted online, it still needs to be prepared properly and it needs to run smoothly. We look at how you can prepare and manage a remote audit in our lead article in the May newsletter. The new medical device regulations will finally come into force on the 26th of this month, after a 12-month delay. We have an overview slide deck for you to download and an explainer on the new role of the PRRC. Feel free to share the newsletter with any of your colleagues. You can use the sharing buttons above.

How To Prepare For A Remote Audit

Current restrictions on travel, brought about by Covid-19, have resulted in the increase in remote audits being carried out by health authorities. While there might not be an auditor sitting across a meeting room table from you, there are still many issues to consider when preparing for a remote audit. This article, from the experts in our Quality Assurance team, looks at how you can prepare for an audit that might be carried using a virtual technology tool. Read the full article here.

Acorn Regulatory Secures MIA Licence

Acorn Regulatory has obtained a Manufacturer’s / Importer’s Authorisation (MIA) licence (otherwise known as an MIA Licence) for Batch Certification of Imported Medicinal Products for Veterinary Use. Find out more here

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. Read more here

Download Our MDR Changes Deck

The new medical device regulations will be introduced later this month. The MDR changes will see an increased set of responsibilities for manufacturers, economic operators, authorised representatives, and distributors. Our MDR regulatory affairs consultants are currently working with companies to help them to prepare for the changes. We have created a slide deck that takes a brief look at the changes. Download it here.

MDR Regulatory Affairs Consultants

MDR (the medical device regulations) will present the most significant changes in the device sector for a generation. Our MDR regulatory affairs consultants are ready to assist your company with any issues related to the new regulations. Read more here

Do You Need A WDA? Here Is What You Need To Know

There has been an increase in the number of companies that have sought our services to assist them in obtaining a WDA. If your company needs a WDA, we can assist you with the process in a timely and professional manner. This blog from our Quality team looks at the issues that you will need to consider if you need a WDA. Read the article here

The 5 Responsibilities of the PRRC

This article is part of our series of MDR articles that look at the changes coming into play with the new medical device regulations. In this article, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC). Read more here. [ninja_form id=75]

Acorn Regulatory’s Pharmaceutical Team

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 here.

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