Christine McGrath

What Are The Common Mistakes With CEP’s?

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

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… Read more

repeat use procedure Acorn Regulatory Regulatory Strategy Consultants

Repeat Use Procedure: What Are The Steps To Consider?

In this article, Christine McGrath, a senior member of our pharmaceutical regulatory affairs team, looks at the issue of Repeat… Read more

Case Study: How To Obtain A Certificate of Suitability (CEP)

We worked with a major US manufacturing firm to obtain a CEP. Our team worked closely with the manufacturing company… Read more

pharmaceutical quality system - Acorn Regulatory

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… Read more