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.
PV Audit Strategy and Risk Assessment
From our experience, companies are falling short of their pharmacovigilance obligations with regards to strategic, tactical and operational level PV audit planning. This can lead to areas of non-compliance, risks to patient safety and inspection findings. Outlined...
Brexit Revisited – Are you prepared for the Windsor Framework?
More than 4 years after the United Kingdom’s exit from the EU in January 2020, the industry is still dealing with the impact of Brexit and the Northern Ireland Protocol. Most recently being the implementation of the Windsor Framework.
BioPharmaChem Impact 24 Conference
We were delighted to attend the 1st ever BioPharmaChem Impact 24 Conference which took place yesterday May 23rd in the beautiful surroundings of Fota Island Resort, Cork.
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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