Veterinary CRO

Phase I to IV
Regulatory Submission
Post Market Surveillance

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Veterinary Clinical Research

BioAgile Therapeutics provides veterinary product clinical research and evidentiary services for veterinary product development such as drugs, biologics, feed additives, nutraceuticals. BioAgile Therapeutics develops a relationship with animal health developers to prepare their product, from research design and clinical evaluation stages to post-market monitoring, safety evaluation, and ongoing regulatory compliance. The end result is a series of veterinary products that comply with the very best standards of safety, efficacy, and animal welfare for both domestic and international commercialization based on VICH guidelines or statutory regional requirements.

Veterinary Clinical Research Excellence

Comprehensive, in vivo investigation of safety is conducted in designated target animal species to determine adverse reactions, tolerability, and overall health effects. Monitoring animal health as part of the safety evaluation process provides scientific, regulatory-compliant evidence to support product approval and responsible usage in food animal agriculture and clinical settings. Efficacy evaluation is conducted in controlled studies to determine therapeutic or functional effect as related to the target species, such as growth performance, disease prevention, or increased health.

VICH Compliance & Regulatory Pathway Expertise.

Bioagile is committed to upholding the Veterinary International Conference on Harmonization (VICH) GL9 Good Clinical Practices (GCP) and leveraging its extensive experience with the International Cooperation on Harmonisation. We provide targeted species clinical trial designs of veterinary drug development pathways to ensure that clinical trials are rigorously designed, harmonized, and evaluated to the highest standards. BioAgile Therapeutics offers substantial expertise in global veterinary regulatory pathways through submissions to FDA-CVM, EMA, USDA-CVB, and other global authorities to demonstrate veterinary product compliance with established safety, efficacy, and quality standards, including editing of the dossier, labelling across multiple regions, biologics licencing and harmonized approval strategies as dictated by VICH and other global guidelines.

Species-Specific Study Design

BioAgile shows depth of experience across species design a study as appropriate for companion animals (dogs and cats), livestock (cattle, swine, poultry), aquaculture species, as well as exotic and laboratory animals for species specific assessment of veterinary products.

Safety & Efficacy Evaluation

We utilize field trials in clinics and farms to assess product usability, safety, and performance, while adding value to user engagement. Field studies capture and generate useful data about user compliance, long-term effects, and other end-user benefits that ultimately build confidence for the end-user and align with decision-making to be market-ready.