Enabling faster approvals and compliant scale for veterinary medicines, supplements, and health products.
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The veterinary medicines sector supports animal health - from livestock productivity to advanced pet care. Driven by pet humanization, food safety, and One Health priorities, the market is growing steadily. Regulatory systems mirror human pharma but with faster timelines. Success depends on species-specific data, residue compliance, and global coordination with food and veterinary safety authorities.
Navigating the Regulatory Maze in Veterinary Products
From drug–feed classification issues to regional import and labelling mandates, veterinary product companies face a patchwork of regulations that delay launches and complicate compliance.
Products are treated as drugs, biologics, feeds, or devices depending on the country - creating submission and compliance confusion.
Each region demands different technical files for efficacy, safety, residue studies, and environmental data - often without harmonized formats.
AE reporting and complaint handling vary greatly - making global post-market compliance difficult to scale.
Vaccines, injectables, and temperature-sensitive biologics require specialized import permits and storage compliance.
Labels must include dosing per species, withdrawal periods, and multilingual translations - with no global standard.
Veterinary oversight is often split across agriculture, food safety, and health ministries - causing delays and dual reviews.
Streamlined Regulatory Solutions for Veterinary Market Access
Clarify regulatory status (drug, biologic, feed, device) and align strategy by region.
From compiling region-specific eCTD dossiers to aligning with US VMF or EU VMP requirements - we ensure your data is compliant, complete, and submission-ready.
Fulfil MAH, sponsor, or legal agent needs in all regions requiring in-market presence.
Our network of accredited labs and native-speaking regulatory professionals ensures smooth adaptation of product specifications, testing, and labelling to local standards.
Set up market-specific AE tracking and complaint handling processes for fragmented systems.
- GRAS/Novel ingredient qualification for feed additives
- Support for new dosage forms or combination products
- Evaluation of alternative registration paths (e.g., monograph-based, conditional approvals)
Your execution-first partner, bridging regulatory precision with innovation acceleration
From fast-track launches to seamless regulatory transitions, see how RegNova powers brands toward global expansion success.
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Let’s accelerate your compliant innovation, market entry success, and global expansion together.
