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
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.
Shortlisted for a Pharma Industry Award
We are thrilled that our Regulatory Team was shortlisted for a Pharma Industry Awards -Pharma Contract Services Company of the Year 2024. Our nomination is for their excellent work on implementing a client Regulatory Information Management (RIM) System.
World Drug Safety Congress, Europe
Our Head of PV is attending the World Drug Safety Congress during 9-10th October in Amsterdam this year. This is Europe's Most Exciting Drug Safety and PV event and with over 90+ exhibitors, 300+ speakers and 1,500 PV experts in attendance, it promises to be a truly...
CPHI Milan 2024
On Oct 8-10th CPhI Milan 2024 will open its doors to over 60, 000 people. This year, our founder and CEO; Gemma Robinson and Senior Project Manager; Janet Fitzgerald will be in attendance. Pharma professionals from all around the world will converge in Milan for the...
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.
Strategy
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