GMP Manufacturing Authorization Milestone for nuvalore

Leimen, Germany – Independent pharmaceutical and biopharmaceutical analytical characterization laboratory nuvalore GmbH has reached an important regulatory milestone with the granting of a Manufacturing Authorization for GMP-compliant quality control activities.

Following inspection by the Regierungspräsidium Tübingen, nuvalore’s site in Leimen, Germany, has been granted Manufacturing Authorization MIA No. DE_BW_01_MIA_2026_0023. The authorization covers GMP-compliant quality control activities in accordance with §13 AMG and EU Regulation (EU) No. 536/2014.

Authorized GMP Quality Control Scope

The authorization covers quality control activities for human medicinal products and investigational medicinal products for use in humans. The authorized activity is chemical/physical quality control testing, including:

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

This scope enables nuvalore to support pharmaceutical and biotech programs with GMP-compliant analytical testing as they progress from development into clinical and manufacturing phases.

Benefits for Pharma and Biotech Customers

For pharmaceutical and biotech companies, the authorization provides several important advantages:

• Clinical-stage readiness: GMP-compliant QC testing for human medicinal products and investigational medicinal products (IMPs), supporting clinical trial applications, regulatory submissions, audits, and inspections.
• Continuity from development to GMP: Analytical methods developed with transfer and routine use in mind can be executed under GMP, helping reduce rework as programs advance into validation, stability studies, and clinical-stage testing.
• Inspection-ready execution: Testing is performed under a valid EU Manufacturing Authorization, supporting vendor qualification, GMP audits, and inclusion in regulatory submissions and inspection processes.

With this authorization, nuvalore strengthens its role as a GMP-ready analytical partner for pharmaceutical and biotech companies, enabling the generation of compliant, inspection-ready data as programs transition from development into clinical and manufacturing phases.

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 supports pharmaceutical and biotechnology companies with reliable, regulatory-ready analytical data.

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

Resources

View Manufacturing Authorization MIA No. DE_BW_01_MIA_2026_0023.
Explore nuvalore services brochure
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