Veterinary regulatory services
Ensuring veterinary products meet global regulatory requirements is crucial for manufacturers and marketers in the animal health industry. Regulatory Services for Animal Health Products encompass the development, approval, and lifecycle management of veterinary medicinal products, including pharmaceuticals, vaccines, feed additives, and biologicals. At DDReg, we provide end-to-end regulatory affairs services to ensure veterinary products achieve market authorization efficiently while maintaining compliance with evolving regulations.
DISCOVER MOREComprehensive Veterinary Regulatory Affairs Services
Navigating regulations for Animal Health Products requires a deep understanding of regional and international regulations. At DDReg, our expertise spans across multiple global markets, including the USA, EU, LATAM, GCC, and Asia-Pacific. Our veterinary regulatory experts work closely with local competent authorities, developing robust regulatory strategies, providing guidance for regulatory submissions and ensuring smooth interactions to minimize approval timelines. Our team specializes in developing global regulatory roadmaps for preparing and submitting veterinary product registrations such as NADA/ANADA for the US FDA and EU & UK generic veterinary product filings, ensuring compliance with labeling, artwork, and promotional materials, and conducting CMC reviews and gap analyses to enhance submission readiness.
Strategic Risk Management & Regulatory Intelligence
Regulatory landscapes evolve continuously, and staying updated is key to compliance. Our veterinary health products consulting services integrate advanced RegTech solutions to monitor real-time regulatory changes, enabling proactive risk management. We provide up-to-date regulatory intelligence to help businesses anticipate market shifts, conduct risk assessments to mitigate potential compliance issues, and ensure post-approval regulatory support for continued compliance.
Our Veterinary Regulatory Expertise
DDReg offers a broad spectrum of specialized regulatory services designed to streamline the veterinary product approval process. Our services include:
- Veterinary Dossier Preparation & Submission – Assisting in compiling and submitting registration dossiers for global regulatory bodies.
- Labeling Compliance – Ensuring all veterinary medicine solutions meet regional labeling regulations. Is missing, plz add.
- Pharmacokinetic Studies & Regulatory Compliance Reviews – Conducting in-depth assessments of PK data for regulatory adequacy.
- Animal Bioequivalence (BE) Studies & Justifications – Supporting scientific justifications for regulatory submissions.
- CMC Support – Providing detailed CMC reviews, gap analyses, and compliance remediation.
- Post-Approval Lifecycle Management – Handling variations, renewals, and ongoing compliance monitoring.
- Specialized Submissions – Expert support for NADA and ANADA submissions to the US FDA.
- Local Representation & Intellectual Property Support – Offering guidance on regulatory strategy and market exclusivity.
Partner with DDReg for Seamless Veterinary Product Registration