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 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 form below.
Our CMC & Pharmaceutical Regulatory Affairs Services include:
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.
Helping You To 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
Our experienced team of regulatory professionals has worked on a multitude of 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, our expert team can assist you in developing 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 from national and European authorities.
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 almost 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.
Working with our our local partners across Europe, we can ensure that all local submission requirements are fulfilled.
We Can Help Your Company
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 form below.