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 CMC e-book, we have compiled some of the most-read articles into a downloadable PDF.

In this CMC e-book, we will look at the issue of:

  • Repeat Use Procedures,
  • Worksharing
  • and,  the need for many companies to outsource.

The e-book can be downloaded by completing the form below.

Further Reading from Acorn Regulatory

Get The Latest eCTD Publishing Whitepaper Now

Our expert eCTD publishing team has written several whitepapers on issues relating to electronic publishing.  Now, they have compiled the most popular articles from recent months into a free whitepaper for you to download. Download the eCTD whitepaper here.

‘Selected Writing from Acorn Regulatory’

‘Selected Writing from Acorn Regulatory’ highlights just some of the most read articles written by our expert staff in the past 12 months.  This e-book is packed with regulatory and pharmacovigilance insights from the team at Acorn Regulatory.  Download it here. 

‘PV Update’: Get Our Pharmacovigilance E-Book Now

Acorn Regulatory’s pharmacovigilance and medical teams work with some of the largest and most dynamic companies in the world.  They have looked at the major issues impacting their clients at the moment and have created ‘PV Update’ which is our latest PV guide.

‘PV Update’ considers issues such as:

Download our PV whitepaper here.

About the Authors
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts. Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects.
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Christine McGrath
SENIOR REGULATORY AFFAIRS ADVISOR
Christine McGrath is an experienced Senior Regulatory Affairs Advisor at Acorn Regulatory. She works with companies around the world on issues relating to pharmaceutical regulatory affairs. At present, she is also working with our Clinical team on a groundbreaking veterinary clinical trial.
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Eileen Ryan
REGULATORY PUBLISHING MANAGER
Eileen Ryan is the Regulatory Publishing Manager at Acorn Regulatory. In her current role she contributes to the strategic planning/preparation of regulatory submissions in collaboration with other departmental representatives and manages publishing team to ensure the successful publishing of high quality, compliant submissions in the relevant eCTD/NeeS formats to the health authorities.
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Janet Fitzgerald
Project Manager
Janet Fitzgerald manages some of the larger projects that the company's pharmaceutical and CMC team are working on. She has a wealth of experience in the regulatory affairs sector.
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Marie Carroll
Regulatory Affairs Advisor
Marie Carroll is a Regulatory Affairs Advisor with Acorn Regulatory and focuses on issues relating to Chemistry, Manufacturing and Controls. Prior to joining the company she spent over 15 years in senior roles with a large pharmaceutical company.
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Sinead Smyth
Regulatory Affairs Advisor
Sinead Smyth is responsible for supporting the Regulatory Affairs Team in the submission publishing process for the preparation of regulatory documentation in eCTD, NeeS or paper formats as required. Her works involves compiling, formatting and publishing regulatory activities to ensure a high quality, compliant, valid and timely submission to the health authorities.
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