Veterinary
DDReg offers comprehensive veterinary consulting Services to ensure regulatory compliance for animal health products worldwide. With expertise in veterinary dossier preparation, pharmacokinetic studies, and labeling compliance, our team of veterinary pharmaceutical consultants provides tailored solutions for seamless product approvals. We help veterinary medicine manufacturers navigate complex regulatory landscapes, ensuring compliance with global health authorities.
DISCOVER MOREFrom Fragmentation to Integration: Tackling Global Veterinary Regulatory Challenges
Regulatory frameworks governing veterinary products exhibit significant variability across different countries. Each region, including the United States, European Union, India, and Australia, is governed by distinct regulatory authorities, approval processes, and compliance standards. This fragmented regulatory landscape presents considerable challenges for manufacturers, who must navigate a complex web of often conflicting requirements to successfully introduce products to the global market. Streamlining these regulations is essential for facilitating innovation, reducing costs, and ensuring prompt access to safe and effective veterinary medicines on a worldwide scale.
At DDReg, we have worked extensively with global agencies (e.g CVM of US FDA or Vet. Medicines division of EMA) that govern the regulatory system for Veterinary products. With a deep understanding of global veterinary regulations, we assist companies in preparing technical and scientific justifications, ensuring compliance with authorities such as the FDA (for NADA and ANADA submissions), EMA, and other regional agencies. Our expertise extends to evaluating veterinary bioequivalence (BE) studies, helping clients navigate data requirements with efficiency and confidence.
Veterinary CMC & Post-Approval Lifecycle Management
At DDReg, we excel in navigating veterinary regulations, offering comprehensive support that goes beyond regulatory submissions. Our expertise encompasses thorough Chemistry, Manufacturing, and Controls (CMC) reviews for a wide variety of active ingredients and dosage forms, including feed mixes. We are committed to ensuring the highest quality, safety, and consistency in veterinary pharmaceutical products.
Our CMC services involve detailed reviews, gap analyses, and actionable remediation advice to help clients align with industry best practices. Additionally, we provide valuable regulatory intelligence services for animal health products, empowering our clients to stay ahead of changing regulatory landscapes. In our post-approval lifecycle management, our dedicated team supports clients with variations, renewals, and ongoing monitoring. Through strategic planning and execution, we help veterinary pharmaceutical companies maintain compliance throughout their product lifecycle, effectively minimizing risks and optimizing regulatory outcomes.
Our Veterinary Consulting Services
01
Regulatory Affairs
Ensuring veterinary products meet global regulatory requirements is crucial for manufacturers and marketers in the animal health industry.
