Marie Carroll

Guidance for MAHs Covid 19

Expectations for Human Use Products During The Covid-19 Pandemic

The European Commission, the Coordination Group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency… Read more

CMC e-book from Acorn Regulatory

Download our CMC e-book Now

Acorn Regulatory’s team of CMC, pharmacovigilance, quality, clinical and medical devices experts consistently produce articles for the sector.  In the… Read more

Download ‘Regulatory Intelligence 6’ Now

‘Regulatory Intelligence 6’ from Acorn Regulatory looks at the latest trends and issues in the sector. You can download your… Read more

What is KASA FDA

KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application

What is KASA and how will it impact on getting a drug assessed by the US FDA?  We look at… Read more

Moving EU Authorised Representative Authorised Representatives BRexit Acorn Regul;atory Brexit Medical Device

Centralised Procedure Medicinal Products: Brexit Update

How will the UK’s departure from the EU impact on medicinal products for human and veterinary health?  We have written… Read more

CMC Guidelines Update

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… Read more

Brexit & MAH Responsibilities

Brexit and MAH Responsibilities – 5 Critical Points To Consider

The spectre of a ‘no deal’ Brexit looms large in the minds of life science professionals.  What impact will this… Read more

Focus on Variations

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

Marketing Authorisations

Marketing Authorisation Holders – An Overview

Acorn Regulatory’s consultants are experts in the sector.    Members of our team have written extensively on this website and… 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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