Pharmaceutical

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.

Testimonials

I have worked with Acorn Regulatory on many OTC campaigns and at this stage have been more than impressed with the insight and overview that they brought to each of the campaigns we worked on. At times debate has been lively but always working towards the end point to enable work to get done.

Regulatory Affairs Manager for a Top 10 Pharmaceutical company headquartered in the USA.

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.

Testimonials

I would like to thank you for the excellent support you have provided us with on our product. Your reactivity, efficiency, professionalism, and expertise have been great and highly appreciated.

Global Regulatory Affairs Manager for a Top 5 pharmaceutical firm headquartered in Europe.

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.