Acorn Regulatory
Expertise
You Can Trust
Acorn Regulatory can boast 25 years of expertise and reliability supporting pharmaceutical and medical device companies globally. Based in Ireland, a well-known hub for life sciences, provides us with valuable insights and connections within the industry. It’s crucial for pharmaceutical and medical device companies to navigate regulatory requirements effectively, and having Acorn Regulatory as your strategic partner can make a significant difference.
Our focus on providing a bespoke solution, our commitment to excellence in regulatory, quality, and pharmacovigilance ensure your goals and expectations are met first time and every time.
Services
Our Services
Our focus on providing a tailored solution, our commitment to excellence in regulatory, quality, and pharmacovigilance ensure your goals and expectations are met.
Regulatory Affairs
- New Product Registration (Human and Veterinary)
- Lifecycle Management
- eRIM Systems
- Publishing Services
- Strategic Project Management
- Scientific Advice
- MA Holder Compliance
Pharmacovigilance
- Case Processing & Reporting
- Literature review
- Signal Management
- Risk Management
- Aggregate Reports
- Pharmacovigilance System
- EU and UK QPPV
- PV Auditing
Quality
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Wholesale Distribution Authorisation (WDA)
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Contract Responsible Person (RP)
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Quality Systems Support
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Management of WDA activities
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Auditing GDP/ QA
Veterinary
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Manufacturing Authorisation applications
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Management of MIA (Vet)
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EU QP for batch release
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Quality System support
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GMP auditing of 3rd party suppliers
Medical Devices
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CE Mark Certification
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EU Authorised Representative
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PRRC
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Post Marketing Surveillance
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Transition to MDR/ IVDR
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Inspection readiness
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Auditing ISO 13485
Awards
Award-Winning Regulatory Expertise
We are proud to have been recognised with four industry awards in the past year, reflecting our commitment to quality, expertise, and trusted partnership. These achievements are a testament to the dedication of our team and the strong relationships we have built with our clients across the global life sciences community.
Blog
News & Articles
Keep pace with the evolving regulatory landscape. Explore our latest blog posts for insightful articles, industry updates, and expert advice to help you navigate the path to market success.
Rising Summer Temperatures: Protecting Pharmaceutical Warehouses Through GDP Compliance.
As summer temperatures continue to rise, warehouses storing pharmaceutical and medicinal products are under increasing pressure to maintain strict environmental standards. Under EU Good Distribution Practice (GDP) guidelines, temperature-sensitive medicines must be...
Artificial Intelligence in Pharmacovigilance (CIOMS WG XIV)
Purpose This briefing highlights the key implications of the CIOMS Working Group XIV report on Artificial Intelligence in Pharmacovigilance (PV) published in December 2025[1] and outlines considerations for organisations deploying AI in safety surveillance. Strategic...
Meet Christine McGrath – Regulatory Affairs Manager at Acorn Regulatory
At Acorn Regulatory, we’re proud to share the stories of the people who make our company what it is. In this edition, our Founder and Managing Director, Dr Gemma Robinson, sits down with her colleague and friend, Christine McGrath, to discuss Christine’s career...
Contact
Contact Us
Have a question about regulatory compliance for your medical device or pharmaceutical product? Our team of experts is here to help.
Contact us today to schedule a call to discuss your specific needs and explore how Acorn Regulatory can be your trusted partner in achieving regulatory compliance and global success.
Email us :
enquiries@acornregulatory.com
Call us :
+353 (0) 52 61 76 706
Contact
Contact Us
Email us :
enquiries@acornregulatory.com
Call us :
+353 (0) 52 61 76 706
Strategy
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