Veterinary Medicine

Understanding and adhering to regulatory requirements is essential for veterinary medicine manufacturers. EMMA International offers in-depth knowledge of global standards and regulations governing veterinary medicines. We provide expert guidance to ensure that your products meet regulatory standards and maintain compliance throughout the product lifecycle.

Our team has deep experience of working with the FDA’s Center for Veterinary Medicine (CVM) and can help bring that knowledge to your team!

Our Veterinary Medicine Services

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Veterinary Pharma Submissions (NADA, ANDA, and INAD)

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Waiver Fee Requests

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Pre-Approval Inspection Readiness and Prep

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GMP Compliance

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Efficacy and Clinical Study Design

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Environmental Impact Assessment

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Veterinary Product Labeling and Claims Review

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483 and Warning Letter Remediation

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Recall Assistance

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US Agent and Import Assistance

Our regulatory support services for vet medicine includes assessments of study data, CMC documents/records, and compilation of the regulatory submissions. Our regulatory experts will be there every step of the way, from opening your INAD file to successful marketing approval of your product and beyond! Additionally, our experts can help assess and prepare waiver requests for fees, including MUMS (minor use, minor species) waiver requests.

When it comes to the intricate world of vet medicine, don’t trust the compliance of your product to just anybody. Trust the experts at EMMA International to bring your veterinary medicine from concept to commercialization!