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 EMA 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
Life cycle management
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 CTD-format dossiers — covering all modules to the required depth and quality for submission.

  • Module 1–5 compilation
  • Expert statements and overviews
  • Quality, safety and efficacy summaries
  • eCTD preparation and submission

EU procedure management

Full management of centralised, decentralised, mutual recognition and national procedures — including authority interactions.

  • Centralised procedure (EMA)
  • Decentralised procedure (DCP)
  • Mutual recognition procedure (MRP)
  • National procedures

Life cycle management

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

  • Type IA, IB and II variations
  • Line extensions
  • Renewals and periodic reviews
  • Labelling updates

Regulatory intelligence

Monitoring of EU regulatory developments, guideline updates and authority trends — translated into actionable advice for your portfolio.

  • Guideline monitoring and impact assessment
  • Regulatory landscape briefings
  • Authority consultation support
  • Portfolio gap analysis

Labelling & artwork

Preparation and coordination of product information, labelling and packaging artwork across multiple EU markets.

  • SPC and package leaflet drafting
  • Multi-country labelling coordination
  • Artwork review and sign-off
  • Translation oversight
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