ZIVA Health Regulatory Consultancy provides comprehensive product development services for Veterinary Drug Studies, Technical / Medical Writing, Regulatory Affairs and Veterinary Pharmacovigilance
Management of Veterinary Drug Studies
Customised services for the management of Veterinary Drug Studies (Pre-clinical / Clinical / Post-Marketing studies) to achieve desired regulations and regulatory compliance requirements
- Protocol
- Case Report Forms
- Procedures
- Data Recording
- Amendments and Deviations
- Study Monitoring
- Data Review
- Final Study Report
Veterinary Regulatory Affairs
In depth knowledge on EU Regulatory Procedures for the registration of your Innovative / Generic / Generic Hybrid Veterinary Medicinal Product in Ireland and EU
- Veterinary Regulatory Procedures
- Pre-Submission Strategies
- Data Gap Analysis
- Dossier Compilation & Submission
- Response to queries from the Regulatory Authorities
- Handling of Variations & Renewals
Medical Writing
Customised Medical Writing services to meet your requirements to ensure the best service and best value for your product
Regulatory
- Protocol
- Final Study Report
- Expert Reports (Safety, Efficacy and Residue)
- Product Literature
Educational
- Journal Articles
- Poster
- Conference Presentation
- Pharmaceutical Marketing Material
Veterinary Pharmacovigilance
Contact for Pharmacovigilance Services as required by the “Volume 9B of the Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use”
- Pharmacovigilance System Establishment
- Detailed Description of Pharmacovigilance System
- Qualified Person Responsible for Pharmacovigilance (QPPV)
- Staff Training
- PSUR
- Database Management
- Literature Review
Who We Are
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
(Preclinical / Clinical / Post-Marketing)
Veterinary Regulatory Affairs
Medical Writing
Veterinary Pharmacovigilance
