Third-party testing can help bring veterinary products to market faster and more affordably.
FDA compliance in veterinary medicine testing is not only a regulatory requirement but also a benchmark for quality and safety in animal health products. Ensuring the safety and efficacy of veterinary drugs, devices, and food additives is a top priority that directly impacts animal welfare and public health. In this context, the value of engaging a third-party testing laboratory becomes significantly important. Here’s an overview of the process with an emphasis on the role of third-party laboratories.
FDA’s Center for Veterinary Medicine (CVM)
The FDA’s Center for Veterinary Medicine (CVM) oversees the regulation of animal health products. It ensures veterinary drugs, devices, and food additives for animals meet strict standards of safety, efficacy, and manufacturing quality before they are allowed on the market.
The Veterinary Medicine Testing Process
The process of bringing a veterinary medicine product to market is complex and multifaceted:
- Preclinical Trials: These initial studies assess the safety and biological activity of a product in laboratory and animal models.
- Investigational New Animal Drug (INAD) Application: Before clinical trials with the target animal species can begin, an INAD application must be filed with the FDA.
- Clinical Trials: These studies are designed to establish the efficacy and safety of the drug in the intended animal species.
- New Animal Drug Application (NADA): A NADA includes all data from preclinical and clinical trials, proposed labeling, and manufacturing details.
- FDA Review: The FDA meticulously reviews the NADA, confirming that the product is safe and effective and that the manufacturing process is up to standard.
- Post-Marketing Surveillance: The FDA continues to monitor the safety of the product through adverse event reporting and regular inspections.h
The Value of Third-Party Testing Laboratories
Third-party testing laboratories play a critical role in the FDA compliance process for several reasons:
- Independence: Third-party laboratories provide an objective analysis of the product, free from potential biases that may occur with in-house testing.
- Expertise: These labs specialize in regulatory compliance testing and are adept at navigating the complex FDA submission process.
- Advanced Equipment: They are often equipped with state-of-the-art technology that may not be available in-house at a pharmaceutical company.
- Efficiency: Leveraging their specialized skills, third-party labs can often conduct testing more efficiently, accelerating the time to market.
- Credibility: Data from reputable, independent laboratories can add credibility to FDA submissions, facilitating a smoother review process.
- Cost-Effectiveness: Outsourcing testing can be more cost-effective than maintaining the necessary resources and personnel for compliance testing in-house.
Record-Keeping and Reporting
Accurate record-keeping and timely reporting of adverse events are crucial components of FDA compliance. Third-party laboratories ensure meticulous documentation of all testing protocols and results, which is vital for regulatory review and post-marketing surveillance.
How Contract Laboratory Can Help
Engaging a third-party testing laboratory can add significant value to the FDA compliance process in veterinary medicine. These specialized laboratories bring expertise, efficiency, and credibility to the testing and approval process, helping to ensure that animal health products are safe and effective while allowing manufacturers to focus on innovation and product development. As veterinary medicine continues to advance, the partnership between pharmaceutical companies and third-party laboratories will remain instrumental in upholding the standards of animal health and public safety.
Veterinary Medicine Research and Development Testing
ContractLaboratory.com has helped many Veterinary Medicine manufacturers, importers, and distributors with the Research and Development and Testing of their Veterinary Medicine Products.
Below are some examples of Veterinary Medicine Laboratory Test Requests:
- Europe laboratory needed for animal health testing.
- Animal Health company needs a laboratory for certification testing that veterinary feed additives is free of antibiotics before export. Certification must claim that the sample is free from all kinds of Antibiotics including Chloramphenicol and Nitrofurane and Melamine.
- Laboratory needed for glucose comparison studies of assays on samples from diabetic pets. The study involves having glucose assays performed at the same time on the animals on a clinical analyzer.
- Bioanalytical Laboratory needed for bioanalysis assay of progesterone and estradiol on rat serum
- A Veterinary Medicine Laboratory needed for kidney norepinephrine testing in swine
- University Researcher needs a veterinary medicine laboratory for Canine fecal cortisol EIA testing for a pilot study.
- Animal health laboratory needed for Permethrin assays on post-mortem tissue of animals
- USA veterinary medicine laboratory needed for canine serum testing for the breakdown of interferon, an interlude in, etc. in several blood serum samples from a few different K-9 donor dogs. To see what each sample has in regards to the immune system-associated functions. Reverse engineering in what each
- A government agency needs a veterinary medicine laboratory that follows GLP (Good Laboratory Practice. Procedures and results must meet FDA veterinary requirements
- Veterinary Medicine Laboratory needed for blood testing: primaquine determination in animals’ blood plasma
- Los Angeles California veterinary medicine laboratory needed for animal plasma testing: primaquine levels in plasma
- United States or Puerto Rico USDA-approved veterinary medicine laboratory needed for Blood testing
- Australian Laboratory needed for equine serum Testing to analyze exactly what growth factors are evident
- Denmark, Germany, France, and Sweden Laboratory needed genetics Testing To establish normal karyotypes of cattle for international trade
- Animal Science laboratory needed for mouse testing: Swiss albino, BALB/c Mice & CS7b16 Mouse.
- Laboratory needed for animal health examination. looking to have calves that were born weighing 20-30 lbs non-viable autopsied. Needing to know if it is genetics, feed, minerals, or medication problems. We have lost 15% of our calves of this size. Almost all others are born small
- Central USA food laboratory is needed for raw pet food testing for nutrients including amino acids, minerals, vitamins, and fatty acids
- A Veterinary Laboratory needed for pet fecal testing
- Ontario bioanalytical laboratory needed for drug residue testing in horsemeat for performance-enhancing drugs, antibiotics, or other meds?
- A USA or Canadian food laboratory is needed for ingredient testing of pet health supplements. A list of claimed ingredients and a 120 ml sample is available. Want to also determine if the sample contains other ingredients not listed.
And many more that can be viewed at Incoming Veterinary Medicine Test Request Projects
Does your Pharmaceutical Veterinary Medicine Manufacturer, Importer, or Distributor want to avoid withdrawal of their approval and want to use third-party independent laboratories for testing their veterinary capsules, tablets, sterile injections, topicals, or oral formulation drugs for safety? We can help. Contact Us for more information, or Submit Laboratory Test Request
