Pharmaceutical

Interpreting the New CEP Monograph: An Overview

The issue of CEP’s (Certificate of Suitability) arises on a frequent basis.  We have extensive experience of assisting companies in […]

DMF Deadline

The US FDA DMF Deadline: 5 Things You Need To Know

The transition from paper based submissions to electronic Common Technical Document (eCTD) has continued in recent years.  This is something […]

Will The Updated CMC Guidelines Impact On Your Business?

Are you aware of the changes made to the CMC Guidelines on the manufacture of the finished dosage form?  We […]

Scientific Advice Meeting Acorn Regulatory

Advice for Companies Attending Scientific Advice Meetings

In this article, we look at the issue of Scientific Advice Meetings.  This is an area where clients and prospective […]

MRP Group Variations Acorn Regulatory

What You Need To Know About MRP Grouped Variations

We have written extensively on the topic of variations.  The topic of MRP Group Variations arises regularly in conversations with […]

What Are The Benefits Of Smart Packaging In The Pharma Sector?

Much has been written about the benefits of smart packaging for the pharmaceutical sector.  The introduction of smart packaging technologies […]

EDQM CEP Acorn Regulatory

Commonly Deficient Issues When Applying For A Certificate of Suitability (CEP)

The  Certificate of Suitability or CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) […]

Focus On Product Information Labelling

Acorn Regulatory’s consultants are package information leaflet experts.  We have a team dedicated to the creation and testing of package […]

Acorn Regulatory Regulatory Affairs Marketing Authorisation Variations

Focus on Variations

Acorn Regulatory’s consultants are experts in the sector.  Every day our team members are working on behalf of clients to […]

Contact us and enjoy a faster, smoother journey through the maze of European Pharmaceutical and Medical Device legislation with us as your expert guide.
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