);

Christine McGrath

MRP Grouped Variations

What You Need To Know About MRP Grouped Variations

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

What MAH's Need to Know About Outsourcing

What MAH’s Need to Know About Outsourcing

The continued growth of outsourcing of manufacturing in the pharmaceutical industry, and the use of more complicated supply chains means […]

Regulatory Intelligence 5 from Acorn Regulatory

Download ‘Regulatory Intelligence 5’ from Acorn Regulatory

We have published our latest e-book ‘Regulatory Intelligence 5’.  This edition features a number of new articles from our expert […]

What Are The Common Variation Validation Issues? Find Out Here

Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently […]

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 […]

Scientific Advice Meeting Acorn Regulatory

Scientific Advice Meetings – Advice for Companies

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

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) […]

documented

Documented Information Procedures – What You Need To Know Ahead of The Deadline

ISO 9001:2015 Quality Management Systems – Requirements was published in September 2015 with a three-year transitional period. For organisations that […]

Repeat Use Procedure

Repeat Use Procedure: What Are The Steps To Consider?

In this article, we look at the issue of Repeat Use Procedures. We explain what a Repeat Use Procedure is, […]

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