How Are Changing Regulatory Demands Impacting You?

  As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing regulatory demands. Regulators are shifting more responsibility onto manufacturers to instil quality throughout their operations and throughout their product lifecycles. In the past, small and emerging life sciences companies might have functioned sufficiently with manual processes and disconnected systems, but may now be unable to satisfy the requirements of regulators whose fundamental shift is a growing focus on electronic processes, data driven decisions and increased transparency to information. In this Acorn Regulatory whitepaper we look at the demands placed upon companies from the following perspectives:

1. Information Technology.
2. The Drug Supply Chain.
3. The FDA’s Quality Metrics Program.
4. Tightening of Medical Device Regulations.
5. The Quality Element.

In each of the above listed sections, we assess the changing demands being placed upon companies.  While larger companies may find it easier to resource such issues, they present challenges for small and medium sized life science companies. You can download the whitepaper about changing regulatory demands by completing your details below.  We will then email it to you immediately.  While completing your details, you might like to subscribe to our monthly newsletter and stay up to date with the latest news and publications from Acorn Regulatory. [ninja_form id=33]

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

The brief whitepaper also provides a handy drug-device checklist. Download it here.

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?

You can download your copy here.

Download the 3rd Acorn Regulatory MDR Whitepaper

The 3rd Acorn Regulatory MDR whitepaper is available now.  This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and Clinical Investigations under MDR. Download the whitepaper here.

Get The Latest eCTD Publishing Whitepaper Now

Our expert eCTD publishing team has written several whitepapers on issues relating to electronic publishing.  Now, they have compiled the most popular articles from recent months into a free whitepaper for you to download. Read the eCTD book here.