Download the Acorn Regulatory Whitepapers

Since 2016, the Acorn Regulatory whitepapers on issues such as pharmacovigilance, wholesale distribution authorisations, and Brexit have been well received.
Each of the whitepapers offers readers the opportunity to read insights from some of the expert team at Acorn Regulatory.  Our team work hard to produce compelling whitepapers and articles each month and you can download any of the whitepapers here.

Here are just some of the whitepapers that are available right now:

Our Latest Pharmacovigilance E-Book

Our latest pharmacovigilance e-book looks at PSUR’s, key performance indicators and more.  Download the free e-book here.

Regulatory Intelligence: Pharmacovigilance highlights just a small amount of the pieces written by our expert staff in recent times. Many of the pieces featured are new pieces created specifically for this e-book and others are some of the most popular PV articles from our website in recent times.  You can also find out more about our pharmacovigilance services and you can meet some of the team.Pharmacovigilance E-Book

Find out about:

  • PV & Social Media
  • Key performace indicators for pharmacovigilance
  • Good Pharmacovigilance Practice
  • & More!

You can download the whitepaper by clicking the headline above.

WDA Whitepaper – 5 Steps To Obtaining A Wholesale Distribution Authorisation

The WDA process is complex.  Indeed, many companies turn to us to manage the application process on their behalf. In our updated WDA whitepaper, 5 Steps To Obtaining A Wholesale Distribution Authorisation, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence.

Our Wholesale Distribution Authorisation team works in the area day-in and day-out with companies from all over the world.  They ensure that the client secures their Wholesale Distribution Authorisation in a timely and cost effective manner.

In this WDA whitepaper we look at the 5 steps To obtaining a WDA (Wholesale Distribution Authorisation) for your company.

The document, written by Acorn Regulatory expert staff looks at:

a. Defining the supply chain

b. Implementing a Quality Management System

c. The role of the RP

d. Submitting the Wholesale Distribution Authorisation application

e. The HPRA inspection (or inspection by a similar body such as the MHRA)

You can download the whitepaper by clicking the headline above.

Brexit: One Year On – The 5th Acorn Regulatory Whitepaper

Brexit: One Year On is the 5th Acorn Regulatory whitepaper.  In this edition we look at some of the most pressing issues for regulatory specialists such as the changes to marketing authorisations, the need to move EU Authorised Representatives and more.

One year on from the UK’s decision to leave the European Union the negotiations have begun. The life sciences sector is, perhaps, one of the sectors that will be most impacted by the result of the referendum and many companies are setting plans in place to deal with a new regulatory landscape.

In the past year we have published a number of very well received whitepapers and thought leadership articles on the issue of Brexit. Our work has been acknowledged by major media organisations such as Politico and a wide range of niche publications and websites. Now that the negotiations have begun, we think that it is an appropriate time to revisit a handful of the most widely read and quoted pieces from the last twelve months. We are regarded as the industry leaders on the subject and, consequently, we are working with a large number of pharmaceutical and medical device companies on their Brexit related issues. The pieces contained herein look at issues such as marketing authorisations, EU authorised representatives and more.

You can download the whitepaper by clicking the headline above.

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