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

  • Wholesale Distribution Authorisation (WDA)

  • Contract Responsible Person (RP)

  • Quality Systems Support

  • Management of WDA activities

  • Auditing GDP/ QA

Veterinary

  • Manufacturing Authorisation applications

  • Management of MIA (Vet)

  • EU QP for batch release

  • Quality System support

  • GMP auditing of 3rd party suppliers

Medical Devices

  • CE Mark Certification

  • EU Authorised Representative

  • PRRC

  • Post Marketing Surveillance

  • Transition to MDR/ IVDR

  • Inspection readiness

  • 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.

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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