Services

Preclinical & clinical services

Comprehensive study design, management and reporting for pre-clinical and clinical development of veterinary pharmaceutical products.

Preclinical and clinical study management
Our role

Scientific rigour at every study stage

Pre-clinical and clinical data form the backbone of any marketing authorisation application. Regivet provides expert guidance on study design, oversight and reporting — ensuring your data package meets regulatory expectations efficiently and without unnecessary costs.

We work closely with accredited study sites, veterinary clinics and CROs across Europe, managing all aspects of study execution so you can focus on your core business.

GCP and GLP compliant
All target species
EU network of study sites
Full data management
What's included

Preclinical & clinical services in detail

Study design & protocol development

Scientifically robust, regulatory-aligned study designs that generate the data you need — efficiently and without redundancy.

  • Regulatory strategy alignment
  • Study design optimisation
  • Protocol writing (GCP/GLP)
  • Ethics and authority submissions

Clinical field studies

Target animal safety and efficacy studies conducted across our network of veterinary clinics and farms throughout Europe.

  • Site identification and qualification
  • Investigator training and oversight
  • Case report form (CRF) development
  • On-site monitoring visits

Bioequivalence studies

Design and management of bioequivalence and comparative bioavailability studies in compliance with EMA VICH guidelines.

  • PK study design
  • Analytical method support
  • PK/PD data analysis
  • BE report preparation

Data management

End-to-end data management from collection through to clean, analysis-ready datasets and regulatory-standard archives.

  • Electronic data capture (EDC)
  • Data cleaning and validation
  • Statistical analysis planning
  • GCP-compliant archiving

Study reporting

Preparation of complete, regulatory-ready study reports to ICH E3 / VICH GL9 standards, tailored for submission.

  • Clinical study reports (CSR)
  • Target animal safety reports
  • Efficacy summaries
  • Expert statements

Pharmacovigilance support

Post-authorisation safety monitoring and periodic safety update reporting in line with EU pharmacovigilance requirements.

  • Adverse event monitoring
  • PSUR preparation
  • Signal detection and assessment
  • Authority communications
Plan your study

Let's design your development programme

Tell us about your product and target species — we'll outline a preclinical and clinical programme that meets regulatory requirements without generating unnecessary data.

Get in touch