nuvalore receives EU GMP certification for veterinary medicinal products

Leimen, Germany – nuvalore GmbH has received a Certificate of GMP Compliance for veterinary medicinal products, issued by Regierungspräsidium Tübingen following inspection by the competent authority in Germany.

The certificate, DE_BW_01_GMP_2026_0079, confirms that nuvalore’s Leimen facility complies with the principles and guidelines of Good Manufacturing Practice for veterinary medicinal products. The certificate was issued under Article 94(1) of Regulation (EU) 2019/6 and in connection with nuvalore’s manufacturing authorization under Article 88 of Regulation (EU) 2019/6 and Section 28(1) TAMG.

The certified scope covers quality control testing for veterinary medicinal products, specifically chemical/physical analytical methods, including:

• pharmaceutical-chemical analysis
• pharmaceutical-technological analysis
• chromatographic methods
• capillary electrophoresis methods

This certification expands nuvalore’s GMP-authorized analytical capabilities into the veterinary medicines sector and supports manufacturers, developers, and marketing authorization holders navigating an evolving EU regulatory landscape.

Why This Matters – New EU Veterinary GMP Framework Takes Effect in July 2026

This certification comes at an important transition point for the veterinary pharmaceutical industry.

From 16 July 2026, veterinary medicinal products will transition to a dedicated EU GMP framework with legally enforceable requirements specific to veterinary medicines.

Key changes include:

• Introduction of dedicated veterinary GMP regulations under Commission Implementing Regulations (EU) 2025/2091 and 2025/2154
• Separation of the veterinary GMP framework from human medicinal products
• Increased regulatory focus on data integrity, computerized systems validation (CSV), method validation, stability programs, and pharmaceutical quality systems
• Greater scrutiny of GMP authorization status and external quality control partners operating within the veterinary regulatory environment
• Quality control and contract laboratories may need to reassess their authorization and compliance status under TAMG in light of the evolving veterinary GMP framework.

While many technical expectations remain familiar, the regulatory framework and enforcement landscape for veterinary medicinal products are evolving significantly, increasing the importance of veterinary GMP gap assessments and compliance readiness.

Supporting Quality in Animal Health

When pets and animals require medicines, product quality, safety, and robust analytical control are essential.

nuvalore’s EU GMP certification for veterinary medicinal products reflects the company’s continued commitment to GMP analytical testing and regulatory-quality laboratory operations for the animal health sector.

At nuvalore, veterinary medicinal product testing is performed within the same GMP quality framework applied across our regulated pharmaceutical analytical operations — supporting scientifically rigorous, regulatory-ready analytical services.

Healthy pets need safe medicines – quality must never be optional.

About nuvalore GmbH

nuvalore GmbH is a GMP-certified contract quality control laboratory based in Leimen, Baden-Württemberg, specializing in the analytical characterization of pharmaceuticals and biopharmaceuticals.

Founded in 2024, nuvalore supports clients with analytical method development, validation, and transfer, as well as Quality by Design (QbD)-driven approaches using Design of Experiments (DoE). Its capabilities include pharmacopoeial quality control, protein and surfactant analysis, ELISA, nanoparticle characterization, and testing of primary packaging and drug delivery systems.

Operating under a quality management system aligned with EU GMP and ICH guidelines, nuvalore provides pharmaceutical and biotechnology companies with reliable, regulatory-ready analytical data.

To learn more, visit:  https://nuvalore.com/en/

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