In 2016 we published the first edition of our WDA e-book. It has been downloaded hundreds of times since by sector specialists who are interested in getting an initial understanding of the steps involved in securing a WDA.
We have updated the WDA e-book yet again and it is now available to download.
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 2018 edition, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence.
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)
To download a copy of the e-book, complete your details below and you will be taken to the download link. You will also receive an email containing a link to the WDA e-book.
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Have You Downloaded These Publications from Acorn Regulatory?
Drug-Device Whitepaper
The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. Some of the principal changes are in the areas of the role of economic operators, vigilance and post-market surveillance, increased requirements for clinical evidence, and expansion of the scope of products covered under the regulation when compared with the previous directives. This whitepaper provides an overview of the legislative changes, with a focus on the requirements for products that are typically known as drug-device combination products.The drug-device whitepaper looks at issues such as:
- the regulatory framework for devices
- what is a drug-device product and how are they defined as such?
- how are they regulated
- how does MDR change the requirements for drug-device products?
- combination products regulated as medical devices
Download ‘Regulatory Intelligence 8’
Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. This bumper edition looks at a wide range of sectors including pharmacovigilance, CMC & pharmaceutical, and medical device. Download it here.Download ‘Regulatory Intelligence 7’ from Acorn Regulatory
‘Regulatory Intelligence 7’ is now available to download. It is the latest edition in our popular series ‘Regulatory Intelligence’. This edition covers the following issues:- Can You Use a U.S. Dossier to Apply for a European Marketing Authorisation?
- Clinical Investigations Under MDR
- The U.K. PSMF -What Will It Look Like?
