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.
EC proposes downgrading of variation classification for quality changes
The current Variations Regulation, i.e. Commission Regulation (EC) No.1234/2008, was introduced in 2008 with the aim to simplify and introduce more flexibility to the process of post-approval changes to marketing authorisations (MA). A successful variations system...
Revision 2 of ICH Guideline on viral safety evaluation ICH Q5A
Revision 2 of ICH Q5A Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin comes into effect Virus contamination is a major concern for the manufacture of biotechnology products. While products derived from...
New ICH Q2(R2) and ICH Q14 Analytical Procedure Guidelines released
The ICH Q2 Guideline on the validation of analytical procedures applies to the analytical procedures used for release and stability testing of commercial drug substances and products. ICH Q2 has been in existence since 1993, with ICH Q2(R1) coming into effect in...
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
Strategy
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