Christine McGrath

Download ‘Regulatory Intelligence 6’ Now

‘Regulatory Intelligence 6’ from Acorn Regulatory is the latest edition of our e-book series that looks at the latest trends… Read more

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… Read more

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… Read more

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… Read more

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… Read more

Interpreting New CEP Monograph

Interpreting the CEP (Certificate of Suitability) Monograph

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

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… Read more

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)… Read more

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… Read more

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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