Regulatory Affairs

Our Regulatory team have considerable experience working with clients of all sizes to provide a bespoke service to deliver global registrations and continued regulatory compliance. We strive to work efficiently and cost effectively, while ensuring attention to detail and a high standard of work.

Our comprehensive knowledge of the global regulatory environment enables us to develop and implement creative and innovative strategies designed to maximise the long-term success of clients’ products. We closely monitor the evolving regulatory requirements in the EU and UK to ensure or clients are always kept up to date.


Strategic Project Management

Acorn Regulatory will assign a Project Manager to ensure your project is planned with the right level of resource  and expertise and delivered on schedule, withing budget, ensuring a high standard of work.

Timelines and Budgets can be monitored throughout keeping our client and their stakeholders informed of progress with regular status updates. With a flexible approach to project management methodologies, we can tailor our support to meet your needs.


New Product Registration – Human & Veterinary

We have a team of experienced consultants with wide-ranging industry experience in small and large pharmaceutical companies across product types such as Innovator Drugs and Biologics, Generics and Biosimilars, Prescription and OTC Medicines. We have expertise in both Human and Veterinary product registrations.

We can provide the support you need with full Dossier Due Diligence, CMC dossier development and writing. Module 1 preparation including Patient Leaflet User Testing, MAA submission management and regulatory strategy. Enabling you to get your product to market.

“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


Life-Cycle Management

Our team of consultants is experienced with post-approval lifecycle management and compliance. We can support submission of variations, renewals, labelling updates and batch-specific requests.

We can carry out regulatory compliance reviews and gap analysis as well as remediation planning. We provide expert support with regulatory change assessment and submission strategy ensuring compliance with a pragmatic approach.

“Acorn Regulatory have great attention to detail and are very practical. I trust them completely to manage communications with the national competent authorities. They also have a good mind for the project budget and always advise us if there is a need to go over the budgeted hours. We have been working with Acorn Regulatory for many years and are always really happy with the quality of work provided and will use then again for future projects.”

Regulatory Affairs Manager for a Top 10 Pharmaceutical company headquartered in Switzerland


eRIM Systems

We have experience of working within many different client systems for Regulatory Information Management (RIM) and dossier control. We can advise you on the best solution for your individual needs.

Our team can assess your existing electronic or manual systems and help you to prepare and ‘clean’ your data ahead of migration. We can manage the implementation process with support in data migration and computer system validation in compliance with EC and FDA requirements for computerised systems.

“Acorn have been the ‘Best company we have worked with’ for RIM migration. They are ‘setting records’ with the speed and high quality of migration data. Some clients can take 2 years and still not have all data accurate, but Acorn have done this in less than 1 year with less resource.”

Project Manager at RIM Software Provider headquartered in France


Publishing Services

Our publishing team can build, QC check and validate your eCTD submission packages in many global regions including EU, US, Canada, Australia and G.C.C. We can submit to EU National competent authorities (NCA) via CESP and National Submission Portals.

We are experienced in conversion of dossiers from old NTA format or NeeS to eCTD and generating eCTD baselines. Our flexible and competent team can turn your dossier into a submission-ready file with efficiency and quality.

MA Holders

MA Holder Compliance

With the number of ‘virtual’ Marketing Authorisation Holders (MAH), that do not have manufacturing responsibility, increasing in recent years, the need for an MAH Quality Management System (QMS) is becoming more evident.

Acorn Regulatory worked closely with the HPRA to support the development of the EMA Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders. As a full-service provider, we are in a unique position to advise MA Holders on the best approach for their QMS and assist with implementation. Ensuring that all Regulatory, Quality and Pharmacovigilance requirements are met.


Scientific Advice

Acorn Regulatory have significant experience in supporting companies at all stages of the regulatory process. We have frequently been engaged by our clients to discuss regulatory strategy or seek scientific advice for a new indication, a new pharmaceutical presentation, a novel combination therapy or other needs with the following Health Authorities; HPRA (Ireland), BfARm (Germany), FAGG (Belgium), MPA (Sweden), CBG (The Netherlands) and MHRA (UK).