Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticleseCTDGemma RobinsonHow-To & ExplainersPharmaceuticalSubmissions
How Do You Translate Your Non-EU Dossier For The EU Market?
The issues faced when translating a non-EU dossier for the EU market is covered in this blog by the CMC team at Acorn Regulatory.
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Download ‘Regulatory Intelligence’ from Acorn Regulatory
Our team of regulatory affairs experts is regarded as the thought leader in the sector. They have worked on some of the most challenging and groundbreaking regulatory projects in modern times. They regularly write for specialist periodicals and speak...
Do Patient Groups Have A Role In Package Leaflet Creation?
What role do target patient groups have in the creation of a package leaflet? We look at the issue and the directives concerning package leaflets in our blog.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesChristine McGrathPharmaceuticalQuality Management System
A New Approach to The Pharmaceutical Quality System
Is your quality system keeping pace with the changes in manufacturing technology and new thinking in how manufacturing companies approach the issues of quality? Many companies have adopted the pharmaceutical quality system outlined in ICH Q10 and experienced the benefits...
Most Read Pharmaceutical News Stories on AcornRegulatory.com in 2016
The team at Acorn Regulatory has been busy all year working with our global client base. Nevertheless, they have taken time to share their expertise on issues such as risk minimisation, the EU regulatory framework, the Periodic Safety Update Single Assessment...
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Download our WDA Whitepaper
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf.
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Advertising of Medicinal Products – An Overview
Advertising of medicinal products in Ireland is governed by a statutory instrument (S.I.) 541/2007, which transposes into Irish law Titles VIII and VIIIa of Directive 2001/83/EC (as amended by Directive 2004/27/EC). We look at the issues relating to advertising a...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesCase StudyMarketing Authorisation HoldersMDD DevicesMedical DevicesPharmaceuticalRegulatory Affairs
Benefits of Outsourcing Regulatory Affairs
The developments in the market, mergers and the issues associated with pricing pressures applied by governments (such as the IPHA deal and the AMNOG deal in Germany) has caused companies to address internal issues and to seek to minimise the negative...
Get The Industry News Roundup for September
In this month’s roundup of industry news roundup, we will be looking at how the USA and Canada are working to align their submission gateways to assist companies making regulatory applications. We will also look at a new EMA drug...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceuticalRisk Management
Risk Management Plans – What You Need To Know
To address risk minimisation, healthcare companies are required to have RMPs (Risk Management Plans) in place to document identified and potential risks of a drug. A Risk Management Plan will include an Action Plan outlining risk minimisation activities that are...
