Virtual Wholesaling of Medicinal Products: 5 Things You Need To Know
In this article we look at the five things that you need to know when considering virtual wholesaling.
eCTD Deadline: Are You Ready?
The electronic Submission (eSubmission) roadmap has introduced very strict milestones for the mandatory use of eCTD format. Are you aware of the deadlines that have passed or the deadlines that are approaching? So, What does the eSubmission roadmap entail? The...
Outsourcing eCTD in 2019 – Is This The Right Time?
We have referenced it before on our blog: the life sciences sector can learn a lot about outsourcing from the airline industry. In particular, companies should consider outsourcing eCTD projects.
Clinical Trials in Ireland: Is Ireland The Place To Be?
Significant progress has been made in recent years in Ireland to advance the capability in design, conduct, analysis and reporting of clinical trials. Patients, researchers, academics, clinicians and industry along with the Health Research Board have worked tirelessly to develop...
Take Our Brexit Survey
In advance of the next Acorn Regulatory Brexit whitepaper, we are conducting a brief Brexit survey to ascertain attitudes towards Brexit from professionals in the life science sector.
The eCTD Deadline is Looming: Are You Ready?
For those of us working in the regulatory affairs sector, there is always a deadline to contend with. We deal comfortably with client deadlines every day. However, the new deadlines that are causing the most unease in the life sciences sector are...
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Pharmaceutical Code of Practice – Are You Aware of Your Responsibilities?
Acorn Regulatory assists companies in maintaining compliance with a variety of codes of conduct. In this article, we look at the issues surrounding the code of practice that governs pharmaceutical companies in the UK and Ireland. The respective IPHA and...
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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.
