CMC Regulatory Affairs Consultants

Our CMC regulatory affairs consultants are experts who have considerable expertise in the sector. From preparing the eCTD dossier and marketing authorisation right through to renewal, our team has extensive expertise in supporting clients with their pharmaceutical regulatory affairs needs.

Headed by our Managing Director, Dr. Gemma Robinson, our team of CMC regulatory affairs consultants work with clients on projects in both human and veterinary sectors.

The projects that we undertake on clients behalf are of varying complexity. You can read some of the feedback that we have recently received from clients here.

Every project that we work on is different.  Below, we have listed some of the most frequently requested services from Acorn Regulatory’s CMC and pharmaceutical regulatory affairs team.

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 form below.

Regulatory Strategy

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

Understanding your 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. 

Helping you to achieve your 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 and working with clients globally – we have over 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 life cycle 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. 

Furthermore, we work with our local partners across Europe we can ensure that all local submission requirements are fulfilled.

We Can Help You

In brief, Acorn Regulatory is an accomplished provider of pharmaceutical regulatory affairs services to companies around for the world for over 20 years.  Our team can assist you in creating an effective 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 form below.