Services

Regulatory affairs

Strategic regulatory guidance and hands-on dossier support — from first assessment through to market authorisation and beyond.

Regulatory affairs dossier preparation
Our role

Navigating European regulation with confidence

The European regulatory landscape for veterinary medicines is complex and constantly evolving. Regivet’s regulatory affairs team has deep experience with European procedures, national authority requirements and the practical realities of getting a product to market across multiple EU member states.

We work as an extension of your regulatory team — or as your dedicated regulatory function — providing clear, actionable advice that keeps your project moving forward.

All EU registration procedures
EMA and national authorities
New products and generics
Regulatory success, together
What's included

Regulatory services in detail

Regulatory strategy

Early-stage strategic advice on the most efficient route to authorisation — matched to your product, data package and commercial objectives.

  • Procedure selection and planning
  • Data gap analysis
  • Pre-submission meetings (EMA/NCA)
  • Scientific advice requests

Dossier compilation

Preparation of complete, high-quality dossiers — covering all parts to the required depth and quality for submission.

  • Quality module (part 2)
  • Safety module (part 3)
  • Efficacy module (part 4)
  • Critical expert reports

EU procedure management

Full management of centralised, decentralised, mutual recognition and national procedures.

  • Authority interactions
  • vNees preparation and submission
  • List of questions
  • National phase(s)

Life cycle management support

On demand regulatory maintenance and variation management to keep your marketing authorisation current and compliant.

  • Support and submission of VRAs, VNRAs and MAH transfers
  • Access to electronic submission platforms (UPD, IRIS, VMDS, CESP)
  • Compliance maintenance

Regulatory intelligence

Helping you stay ahead of regulatory changes with practical insights and clear guidance.

  • Monitoring changes in legislation and guidelines across Europe
  • Actively involved in industry networks and regulatory discussions
  • Maintaining close contact with EMA, CMDv and national authorities
  • Spotting risks and opportunities at an early stage

Pharmacovigilance (coming soon)

Practical support for your pharmacovigilance obligations.

  • QPPV services
  • PSMF support
  • PV quality systems
  • Safety reporting and follow-up
Plan your regulatory pathway

Let's map your route to authorisation

Share your product and data situation — we'll outline the most efficient regulatory pathway and give you a realistic picture of timelines and requirements.

Get in touch