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Animal Pharma New Zealand ltd

Animal Pharma NZ Ltd | Services

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GLP

Good Laboratory Practice

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  • Residue studies

    The determination of analytes and metabolites in milk and meat is essential for upholding national and international safety standards. APNZ works with analytical laboratories in New Zealand and overseas to provide high quality GLP compliant studies to fulfil dossier requirements for registration of new products and label changes for existing products. This comprehensive assessment encompasses a wide array of substances, from pesticides to veterinary drugs, guaranteeing the safety and integrity of your products.

  • Bioequivalence studies

    Bioequivalence studies are designed to determine and compare the pharmacokinetic parameters of formulations to determine bioequivalence or non-interference of two or more products. These studies serve as a cornerstone in pharmaceutical development and require multidisciplinary input from study design and residue testing to statistical analysis. This critical assessment ensures that generic medications deliver the same therapeutic effects with equivalent rates of absorption, distribution, metabolism, and excretion, thereby upholding standards of efficacy and safety. APNZ has an excellent understanding of BEQ studies and over two decades of experience running these studies.

  • Target animal safety studies

    Ensuring the safety and well-being of animals underpins the ethical conduct of veterinary pharmaceutical development. Through compendious safety evaluations, APNZ carefully and comprehensively assesses the potential risks posed by accidental overdose of animal pharmaceuticals. By adhering to rigorous testing protocols and ethical guidelines, we mitigate potential harms and uphold the welfare standards of companion animals, and, production animals.

  • Animal transfer studies

    Animal transfer studies investigate the transfer of agrichemicals from food crops to animals via animal feed. Some countries require the examination of these residues from the plant material to the animal to establish the relationship between residues concentrations if feed (and/or soil), and the residues in food of animal origin.

  • Efficacy

    At APNZ, we have a wide range of knowledge and experience in efficacy studies. Working across the country, we have access to a wide range of farm types and locations. We work with all production animals across the country to get distinctly different geographical locations as needed for registration. This evidence-based research provides animal pharma companies with the necessary efficacy data required for product registration.

  • Intra-mammary

    The intramammary route of drug administration holds significant implications for the management of bovine mastitis and dairy herd health. APNZ has vast experience working with intramammary products – dry cow, teat seals and milking cow products. Gina was part of the Mastitis Research Centre at Massey University for a number of years and has maintained a good depth of knowledge and experience in this field.

  • Vaccines

    Vaccines represent one of the most effective tools in modern medicine for preventing infectious diseases and safeguarding public health. We conduct the pre-clinical and clinical trials (including experimental challenge studies), assess vaccine safety, efficacy and long-term protective effects, which are necessary for product registration studies. Through our extensive contacts around New Zealand, we can find suitable farms and animals for any study.

  • Endo- and ecto-parasiticides

    The control of endo- and ecto-parasites is essential for preserving the health and productivity of livestock, companion animals. With the known triple drench resistance in sheep and the looming resistance in cattle, endo-parasiticide development is pivotal to the continuance of farming in New Zealand. APNZ can conduct studies from FECR studies to total worm burden studies and have the facilities and team required for this work.
    Based on our experience, APNZ is able to find lice and tick sites, and is able to implement and conduct well-designed studies to satisfy the regulatory bodies.
GCP

Good Clinical Practice

Other Services

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  • Pilot/proof of concept studies

    Pilot and proof-of-concept studies (any pharmaceutical, target pest, disease or species) serve as pivotal milestones in the drug development process, providing critical insights into efficacy, safety, and feasibility. Through innovative trial designs and strategic collaborations, we can evaluate novel therapies and interventions in real-world settings, demonstrating their potential benefits and guiding further development efforts. And importantly, we can do these cost-effectively.

  • Study Monitoring

    Effective study monitoring ensures the integrity, quality and compliance of clinical trials and research endeavours. Through quality supervision, APNZ study monitors uphold standards, regulatory requirements and protocol adherence. By conducting site visits, data reviews and participant assessments, we mitigate potential non- compliance, address protocol deviations and optimise study outcomes.

  • Marketing Studies

    Marketing studies provide invaluable insights into consumer preferences, market dynamics and product positioning strategies. While not directly involved in the marketing per se, APNZ can conduct studies required for marketing in broad range of farming types, right across New Zealand.

  • Research Approval and Provisional Registrations

    Research Approval is required for a new product that is not its final formulation whereas Provisional Registrations are required for the final formulation that is to be trialled and marketed. APNZ can compile these documents on behalf of animal pharma companies, and plan the studies that are required to complete a dossier.