nuvalore GmbH
Profile
nuvalore GmbH, based in Leimen, provides analytical services for the pharmaceutical industry, including method development and validation, stability and release testing, and consultancy on Quality by Design.
Services
Evidenced: named on the company’s own website. Unclear: checked, nothing conclusive found.
| Service | Status | EvidenceQuote from the company’s website (German) |
|---|---|---|
| Contract analytical testing Testing and analytics |
Evidenced |
„Routinemäßige Arzneibuchprüfungen – ph-Wert, Osmolarität, Klarheit, nicht sichtbare Partikel und entnehmbares Volumen“ Source · 10 Nov 2026 ↗ |
| Stability testing Testing and analytics |
Evidenced |
„Nuvalore führt ICH-konforme Stabilitätsstudien durch, um sicherzustellen, dass dein Arzneimittel während der gesamten Haltbarkeitsdauer seine Qualität“ Source · 10 Nov 2026 ↗ |
| Analytical method development and validation Testing and analytics |
Evidenced |
„Bei nuvalore bieten wir GMP-konforme End-to-End-Dienstleistungen zur Entwicklung, Validierung und zum Transfer analytischer Methoden“ Source · 10 Nov 2026 ↗ |
| QM and GMP consulting Release and quality |
Evidenced |
„Aufbau von Qualitätsmanagementsystemen (QMS) Lebenszyklusmanagement analytischer Methoden und Behördenkonformität“ Source · 10 Nov 2026 ↗ |
Official credentials
Manufacturing authorisation
The competent authority of the federal state authorises the site to manufacture, test or import medicinal products (Section 13 of the German Medicinal Products Act, AMG). Without this authorisation it may not do so.
DE_BW_01_MIA_2026_0034
Leimen
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗GMP certificate
The authority has inspected the site and confirmed that it complies with Good Manufacturing Practice (GMP).
DE_BW_01_GMP_2026_0079
Leimen
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗Sites
Paul-Ehrlich-Strasse 1
69181 Leimen