Regulatory Veterinary Services

Regulatory Affairs Services for Veterinary Products

Regulatory Affairs services for veterinary products involve ensuring that animal healthcare products, including pharmaceuticals, vaccines, feed additives, and biologicals, comply with applicable regulatory requirements in different regions. These services help veterinary product manufacturers and marketers to understand complex regulatory frameworks in veterinary medicine, ensuring products are safe, effective, and properly labeled.

At DDReg, we offer end-to-end regulatory services to streamline the approval and lifecycle management of veterinary medicinal products. Our comprehensive services and global regulatory expertise enable clients to address regulatory challenges effectively and achieve their commercialization goals.

Why Choose DDReg for Veterinary Regulatory Affairs?

• Proven Expertise in Regulatory Affairs
With extensive experience in the regulation of veterinary products, DDReg has supported over 100 submissions across multiple global markets.

• Global Reach with Local Insights
With its reach in key regions—USA, EU, LATAM, GCC, and Asia-Pacific—DDReg provides key insight into local requirements based on its interface with local competent authorities , thus further enriching it portfolio of veterinary regulatory consulting services. Our strong network of local agents ensures seamless interactions with regulatory bodies, enhancing approval timelines and minimizing barriers to entry.
• Tailored Solutions for Veterinary Products
Our services are customized to meet the unique requirements of veterinary pharmaceuticals, including food-producing and companion animal products. We specialize in market-specific regulatory strategies , dossier preparation, and Post approval lifecycle management to address every stage of the product journey.
Comprehensive Regulatory Support

DDReg covers the entire regulatory spectrum, including:

Development of global regulatory roadmaps.

Preparation and submission of New Veterinary medicine filings, generic vet product filings within EU & UK as well as NADA/ANADA filings to US FDA.

Labeling, artwork compliance, and promotional material review for veterinary medicine solutions.

CMC reviews and gap analysis to ensure readiness for submissions.

• Regulatory Intelligence and Risk Management
With cutting-edge tools and RegTech capabilities, we provide real-time updates on regulatory changes, enabling proactive compliance. Our risk assessments and post-approval support ensure your products remain in line with evolving standards.
• Commitment to Quality and Compliance
DDReg operates under TÜV SÜD ISO 9001:2015 and ISO 27001 certifications, ensuring adherence to stringent quality and information security standards. This commitment guarantees the reliability of our services and the security of your sensitive data.
• Exceptional Success Rates and Accelerated Timelines
Our meticulous approach and deep regulatory expertise have consistently delivered success, achieving market authorization in as little as 6 to 15 months.

DDReg’s Veterinary Regulatory Services Portfolio Includes:

Veterinary Dossier prepartion & Submission of registration dossiers for global regulatory bodies.

Labeling Compliance

Pharmacokinetic Studies reviews for regulatory adequacy & compliance.

Animal BE studies & Justifications

CMC Support (CMC reviews, gap analyses, and remediation)

Post-Approval Lifecycle Management

Specialized Submissions (Expertise in NADA (New Animal Drug Applications) and ANADA (Abbreviated New Animal Drug Applications) submissions to the US FDA)

Local Representation

Intellectual Property Support

DDReg: Your Trusted Partner in Veterinary Regulatory Consulting

With more than 15 years of experience in regulatory affairs, DDReg is dedicated to providing veterinary medicine solutions that cater to diverse market needs. Partner with us to navigate the complexities of Veterinary RA outsourcing providers and achieve rapid market access for your products.

Contact us today to learn how DDReg can support your veterinary regulatory needs.