Research Services
We have extensive experience in preparing study protocols and final reports that meet international quality standards such as GLP, GCP, and compliance with recognised guidelines for studies submitted to the FDA and EMA.
Our expertise is providing animal models to generate in vivo data to:
- Develop new veterinary medicines and vaccines
- Evaluate the toxicity of medical and biological compounds
- Evaluate safety and efficacy of compounds and medical devices
- Demonstrate the safety/tolerance of pharmaceuticals
- Investigate proof of concept for new compounds
- Conduct clinical trials (GCPv, VICH)
Studies we conduct include but are not limited to:
Target Animal Safety
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Studies can be conducted in all species to GCP, GLP and including VICH protocols, incorporating gross post-mortems and detailed histopathological examinations.
Efficacy
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Investigates the benefits and harms of an intervention under highly controlled conditions. Conducted to VICH GL9 (GCP).
Residue
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Milk and Tissue depletion studies in food producing animals. Conducted to GLP according to VICH GL48.
Pharmacokinetic & Toxicokinetic
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Pharmacokinetic and toxicokinetic studies to GCP and GLP as required, including pivotal bioequivalence trials to support product registration locally and internationally.
Proof of concept
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Product development projects can’t move forward without the evidence to support that a viable product can be produced, and minimum efficacy is achieved. The scope of Proof of Concept we conduct include Efficacy, Safety, Tolerance, Dose determination, Palatability, and Digestibility.
Preclinical studies for biomedical research for human applications
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GLP safety and toxicity studies to GLP standards (e.g. Limit test, GLP 408, 404, 427, and more) for the human pharmaceutical industry are also conducted at ERL in collaboration with other high standard research institutions.
ERL has additional expertise and experience in the conduct of other research studies including mastitis challenge models, infectious disease challenge models in production animals (e.g. Leptospirosis, Salmonella and BVD), and vaccine batch testing in laboratory and production animals.
Animal Ethics Committee
ERL possesses its own independent Animal Ethics Committee (Kaiawhina AEC) where animal ethics applications for research projects are assessed monthly. Join the list of parent organisations who utilise these committee here.
Consultancy
We offer a basic consultancy service, advising you on Regulatory Applications and provisional registrations. If you’re looking for more, we can refer you to someone on our long list of research contacts.
Training
GDP/Quality
Quality is ERL’s most inner core value and if you’d like to instil this in your team, we have a wealth of knowledge available for training opportunities.
Talk to us if you and your team would like to improve the quality of your work and systems.