When it comes to developing safe, effective, and compliant animal health products, analytical processes play a critical—yet often underappreciated—role. Whether for veterinary pharmaceuticals, biologics, or medicated feeds, the rigor and precision of analytical methods are central to ensuring product quality, consistency, and regulatory approval.
At DSI, we partner with veterinary medicine developers to deliver industry-leading analytical expertise that supports the entire product lifecycle. From method development and validation to stability assessments and regulatory submissions, our services are tailored to meet the unique challenges of veterinary product development—where the stakes are high, speed is paramount, and the standards are just as stringent as human health. Unlike human drug development, the veterinary model does not follow a linear, three-phase clinical process, which often results in compressed timelines and places greater time pressure on early analytical method development. This makes it even more critical to get the science right the first time.
Why Analytical Methods Matter in Animal Health
Analytical methods are the foundation for verifying the identity, strength, quality, purity, and stability of veterinary products. These methods provide the data necessary to demonstrate that a product is consistent from batch to batch and performs as expected—safeguarding both animal welfare and the food supply.
In animal health, analytical testing also plays an added role: protecting the human population from potential risks through food-producing animals. For example, veterinary drugs used in cattle, poultry, or swine must be tested for residues in edible tissues such as liver, kidney, or milk. FDA's Center for Veterinary Medicine scientists ensure that the analytical methods developed for residue detection are accurate, reproducible, and capable of measuring drug levels within legally established tolerances. Without this level of precision, consumers could be exposed to drug residues in food products.
Analytical Challenges Unique to Animal Health Products
While the principles of analytical chemistry are consistent across human and veterinary medicine, animal health products pose several unique challenges that require tailored expertise:
1. Species Variability
Veterinary products must be tested and validated across a wide range of species—each with different metabolisms, dosing requirements, and physiological characteristics. Method development for an intramammary antibiotic in dairy cows, for example, is vastly different than developing an antiparasitic chewable for dogs or an injectable vaccine for poultry. Dose forms may vary between species resulting in the potential for different types of analytical interferences due to different excipients and preparation mechanisms.
2. Intra-species Dose Differences
Due to intra species size differences, veterinary pharmaceuticals frequently have significantly wider range of dose strengths and sizes resulting in challenges in generating identical and suitably discriminating analytical method conditions to monitor drug release for in vitro – in vivo correlation and bioequivalency studies. Strategically planned and timely executed dissolution method development, validation and discrimination confirmation activities at can help avoid Agency questions upon review.
3. Tissue Residue Monitoring
Unlike human drugs, many veterinary pharmaceuticals must undergo residue depletion studies to establish withdrawal periods (the time needed before an animal’s edible products are considered safe for consumption). Analytical methods must be developed to detect trace levels of drug residues in complex tissue matrices such as liver, kidney, muscle, eggs, or milk.
4. Multi-Use and Combination Products
Veterinary medicines often come in formulations that combine multiple actives or are designed for both prevention and treatment. Analytical methods must be developed to distinguish and quantify each component accurately, frequently at significant different levels—even in challenging dosage forms like medicated feeds, soft chews, or oral drenches.
5. Conditional Approvals and Diverse Pathways
In animal health, regulatory agencies such as FDA-CVM and USDA-CVB offer conditional approval pathways for certain drugs and biologics. These pathways require rigorous, phased analytical support—from investigational product characterization through post-market surveillance—to ensure continued product safety and compliance.
DSI’s Analytical Expertise for Veterinary Product Success
DSI provides comprehensive analytical services for the veterinary industry, combining deep technical knowledge with decades of regulatory experience. Our consultants average over 30 years of experience and specialize in working with a diverse range of veterinary dosage forms, species, and therapeutic classes.
Our services include:
- Method Development, Optimization, and Validation: We direct the generation of robust analytical methods in collaboration with CMOs, ensuring they are appropriately designed, executed, and aligned with your regulatory pathway.
- Impurity Profiling & Stability Testing: We evaluate the chemical stability and degradation profiles of your products under VICH-recommended conditions, ensuring product quality throughout shelf life.
- Residue Method Development: Our team assists in developing methods that meet CVM’s rigorous requirements for residue testing in edible tissues.
- Bioanalytical Support for Clinical Trials: From PK studies in companion animals to residue depletion in livestock, we design methods to support your data package.
- OOS/OOT Investigations and Risk Assessments: We troubleshoot anomalies, perform root cause analyses, and implement corrective actions—often where CDMOs fall short.
- Regulatory Submission Support: We author or review the analytical sections of eCTDs and work directly with FDA CVM, USDA CVB, and EMA to address agency comments.
Regulatory Considerations: Aligning with FDA CVM and USDA CVB
Understanding the expectations of veterinary regulatory authorities is key. At DSI, we have direct experience preparing submission-ready data for:
- INADs, JINADs, NADAs, ANADAs, and CNADAs for FDA-CVM
- Product Licensing Plans, Master Cell Stock Testing, and Summary Information Format (SIF) for USDA-CVB
- Veterinary applications under EMA and VICH guidelines
Our regulatory-CMC specialists ensure that your analytical sections meet the specific requirements for veterinary products—not simply repurposed from human health templates.
The Bottom Line: Accurate Testing = Safe Animals, Safe Food, and Timely Regulatory Success
Robust analytical methods don’t just check a box—they ensure that veterinary drugs, biologics, and medicated feeds meet the highest standards for quality, safety, and efficacy. For animal health companies, this translates into faster approvals, smoother market entry, and long-term commercial success.
At DSI, we combine analytical science with regulatory strategy to deliver data you—and global regulatory authorities—can trust. Our track record includes first-pass approvals of analytical method packages and minimizing regulatory review cycles, helping clients accelerate time to market.
Ready to talk about your veterinary analytical needs?
Partner with DSI to ensure scientific excellence, regulatory alignment, and successful outcomes for your animal health product.
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