Your Reliable Partner

For the Management of Veterinary Drug Studies

Your Reliable Partner

For Veterinary Pharmacovigilance

Your Reliable Partner

For Veterinary Regulatory Affairs

Your Reliable Partner

For Medical Writing

ZIVA Health Regulatory Consultancy is a multi-specialist consultancy which provides comprehensive product development Services to the SME, Startup and Established Animal Health Companies in Ireland and in the EU

Management of Veterinary Drug Studies

  • Management and auditing of single- and multi-site pre-clinical / clinical / post-marketing studies
  • Scientific advise on study planning and experimental design
  • Clinical trial application to the HPRA (Health Products Regulatory Authority)
  • Protocol development in compliance with the current guidelines and regulatory requirements
  • Data Capture Forms / Case Report Forms preparation
  • Placing field studies with experienced Veterinary Investigators to meet study specific requirements
  • Placing GLP, GCP and GXP studies in an established Contract Research Organisation
  • Final Study Report preparation
  • Site visits and study monitoring
  • Trial Master File Compilation

Your reliable partner for the management of your Preclinical/Clinical/Post marketing studies

Your reliable partner for the management of your product marketing authorisation application and also post approval compliance management

Veterinary Regulatory Affairs

  • Regulatory strategies: consultation on application planning and submission
  • Preparation and submission of dossier
    • National Procedure
    • Decentralised Procedure (DCP)
    • Mutual Recognition Procedure (MRP)
    • Centralised Procedure
  • Updates on existing dossier
    • Variation and renewals
  • Detailed and critical summaries
  • Post-approval compliance management

Medical Writing

  • Manuscript preparation and publication in peer reviewed journals
  • Scientific Poster
  • Conference Power Point Presentation
  • Study protocol
  • Final Study Report
  • Standard Operating Procedure
  • Pharmaceutical Product Literature and Labelling

Your reliable partner for your educational and regulatory medical writing requirements

Your reliable partner for the operation and maintenance of your pharmacovigilance system and also adverse event management

Veterinary Pharmacovigilance

  • QPPV (Qualified Person Responsible for Pharmacovigilance)
  • Adverse event management
  • Preparation of Pharmacovigilance Standard Operating Procedures and Detailed Description of Pharmacovigilance System (DDPS) to meet Part 1 requirements of the Dossier and also Pharmacovigilance agreement requirements with the Marketing Authorisation Holder
  • Registration of an organisation with the Eudravigilance Veterinary
  • Compilation, review and submission of PSUR (Periodic Safety Update Reports)
  • Pharmacovigilance staff training
  • Pharmacovigilance database management
  • Literature review for monitoring of published adverse events and other pharmacovigilance issues
  • Pharmacovigilance services for field GCP veterinary trials

Consultation Services

  • An import licence application under the “Cascade” for animal remedies authorized in other EU Member States
  • Nutritional supplements, their product labelling and other regulatory requirements
  • Biocidal notification to the Department of Agriculture, Food and the Marine, to obtain the PCS number

Regulatory & Product Launch service in Middle East in collaboration with a partner company based in the UAE

Your reliable partner for consultation services