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.
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...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsGemma RobinsonHow-To & ExplainersPharmaceuticalPharmacovigilance
Periodic Safety Update Single Assessment (PSUSA) – An Overview
In this blog, we look at the Periodic Safety Update Single Assessment or PSUSA.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesFeatured NewsHow-To & ExplainersIVD DevicesMDD DevicesMedical Devices
CE Marking a Medical Device
CE marking a medical device and placing it on the market in the EU requires several steps that need to be taken. In this blog article, we look at the steps and the questions that you need to ask.
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersQuality Management SystemTraining
Conducting Internal Audits – Guidance from our Quality Team
Our quality team has a well deserved reputation for excellence. In this blog they share their thoughts on what you need to do when conducting internal audits at your facility. Guidance on conducting Internal Audits – ISO 9001:2008 ISO 9001:2008 8.2.2...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesComplianceFeatured NewsHow-To & ExplainersIndustry NewsIVD DevicesMarketing Authorisation HoldersMDD DevicesMedical DevicesRegulatory Affairs
Do You Want To Find Out About CE Marking An App? Find Out More Here
There has been a veritable explosion in the number of mobile apps which act as aids to patients and clinicians – everything from medication reminders to apps which calculate drug dosage. In this brief overview we look at CE Marking an App....
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