Our Services

Regulatory Affairs

Our Regulatory team has considerable experience working with clients of all sizes to provide a bespoke service to deliver global registrations and continued regulatory compliance. 

Our Regulatory Affairs services are:

  • Product Registration (Human and Veterinary)
  • Lifecycle Management
  • eRIM Systems
  • Publishing Services
  • Strategic Project Management
  • Scientific Advice
  • MA Holder Compliance

Pharmacovigilance Services

We offer complete and comprehensive end-to-end pharmacovigilance services to assist you in meeting your pharmacovigilance obligations according to the latest regulations and guidance.

Our Pharmacovigilance services are:

  • Case Processing & Reporting
  • Literature review
  • Signal Management
  • Risk Management
  • Aggregate Reports
  • Pharmacovigilance System
  • EU and UK QPPV
  • PV Auditing

Quality Services

We have an expanding team of experienced quality consultants who have dealt with all aspects of a properly functioning and efficient Quality Management System.

Our Quality services are:

  • Wholesale Distribution Authorisation (WDA)

  • Contract Responsible Person (RP)

  • Quality Systems Support

  • Management of WDA activities

  • Auditing GDP/ QA

Veterinary Services

Acorn Regulatory has worked on numerous veterinary projects over the years, assisting companies bring new veterinary medicines to the European market. We also support companies at all stages of the licencing process, establishing timelines to market and budget management.

Our Veterinary services are:

  • Manufacturing Authorisation applications
  • Management of MIA (Vet)
  • EU QP for batch release
  • Quality System support
  • GMP auditing of 3rd party suppliers

Medical Devices

Obtaining and maintaining CE Mark Certification can be a complex process. Acorn Regulatory will help you at every stage by determining the correct regulatory pathway for your product; including Notified Body selection and appropriate device classification.

Our Medical Devices services are:

  • CE Mark Certification

  • EU Authorised Representative

  • PRRC

  • Post Marketing Surveillance

  • Transition to MDR/ IVDR

  • Inspection readiness

  • Auditing ISO 13485