CMC & Pharmaceutical Regulatory Affairs Services

Our pharmaceutical regulatory affairs team is staffed by experts who have considerable expertise in the sector.  Every team member has at least 15 years of  experience in the pharmaceutical sector assisting pharmaceutical companies with their regulatory issues.  Since 2002, our pharmaceutical regulatory affairs specialists have been working with clients all over the world.

We work with clients around the world on projects of varying complexity. You can read some of the feedback that we have recently received from clients here.  Below, we have listed some of the most frequently requested services.  Yet, every project is different.  If you would like to speak to us about your project, then please contact us by calling 00353 52 61 76706 or by using the webform below.

Regulatory Strategy

In an effort to bring products to market, many companies underestimate the importance of a carefully prepared regulatory strategy. 

Understanding the bigger picture

Our team of experts has considerable expertise in developing customised regulatory strategies for companies of all sizes.

This expertise can help clients to better understand the ‘bigger picture’ of manufacturing and supply chain issues that need to be addressed. 

Achieve strategic aims

A carefully planned regulatory strategy enables companies to achieve global registrations efficiently.

Irrespective of company size or product portfolio; it is essential for any company to create an effective regulatory strategy. Our team of regulatory specialists will advise you and help to devise a practical regulatory strategy to ensure a successful outcome for your project.

Product Registrations & Maintenance 

Regulatory Applications

Our experienced team of regulatory professionals have worked on many different regulatory application types over the years, from national applications to numerous European procedures such as MRP, DCP, CAP to DMF’s and CEP applications.

Whatever your need is we have the expertise to develop a robust regulatory dossier for your company. 

Due Diligence & Expert Report Writing

Our cross-functional team can provide you with the complete solution, from due diligence reviews to Expert Report writing. We can provide you with the documents required to gain approval. 

Regulatory Compliance

With increased pressures on profit margins, regulatory compliance between registration dossiers and practices at manufacturing sites are often neglected.

Acorn Regulatory will work as your partner and ensure regulatory compliance is achieved in a cost effective manner. 

Located in Ireland – we have 20 years of experience of successfully working with companies ensuring regulatory compliance with FDA, EU and ROW Competent Authority expectations.

Electronic Publishing Services 

At Acorn Regulatory, we have a dedicated publishing team who can support you in building your submission package in eCTD (or NeeS) and submitting these to the national competent authorities (NCA) either by CESP or through the national portals as appropriate for Europe and also to the FDA via the Electronic Submission Gateway (ESG).  

If you are moving from a paper based system to eCTD, we can take your raw dossier and format the file for electronic submission in a hassle free manner. 

Our flexibility and our experienced team, means that we are able to convert your dossier to a submission ready file in a much quicker time than our competitors.  

We offer full lifecycle management within our EDMS and we can take care of every sequence that is prepared for you. We also QC review each application prior to publishing to ensure a successful submission. Furthermore, we carry out a post-publishing QC review to ensure that every aspect of your submission has been covered. 

With our local partners across Europe we can ensure that all local submission requirements are fulfilled.

We Can Help

In brief, Acorn Regulatory is an accomplished provider of pharmaceutical regulatory affairs services to companies around for the world for almost 20 years.  Our team, detailed below, can assist you in creating a solution that works best for your company.

Contact us today if you would like us to assist you.  You can contact us by calling 00353 52 61 76706 or by completing the web form below.

Meet the CMC & Pharmaceutical Team
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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