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Nuvisan GmbH

Not yet confirmed Manufacturing authorisation GMP certificate 89231 Neu-Ulm · Bayern nuvisan.de ↗

Profile

Nuvisan GmbH, based in Neu-Ulm, is a contract research organisation (CRO) with laboratories in Germany and France. It conducts clinical trials and recruits trial participants at its own clinical research sites.

Services

Evidenced: named on the company’s own website. Unclear: checked, nothing conclusive found.

ServiceStatusEvidenceQuote from the company’s website (German)
Contract manufacturing of solid dosage forms
Manufacturing
Evidenced

„In clinical trial supplies, Nuvisan manufactures powder mixtures (active and placebo) and hard gelatine capsules including over-encapsulation for blinding of products.“

Source · 10 Nov 2026 ↗
Filling and packaging
Manufacturing
Evidenced

„Nuvisan is offering primary, secondary and tertiary packaging services including study specific labeling with the highest grade of flexibility and adaption“

Source · 10 Nov 2026 ↗
Contract analytical testing
Testing and analytics
Evidenced

„Our analytical services for small and large molecules include method development, validation, quality control, stability studies, EU re-testing and commercial release.“

Source · 10 Nov 2026 ↗
Stability testing
Testing and analytics
Evidenced

„At our GMP laboratories, we can provide superb support thanks to stability chambers with more than 320 m² of storage and with a wide range of temperatures“

Source · 10 Nov 2026 ↗
Bioanalysis
Testing and analytics
Evidenced

„Nuvisan offers comprehensive bioanalytical and CMC services throughout the entire product life cycle, from early research and development to manufacturing and commercialisation.“

Source · 10 Nov 2026 ↗
Analytical method development and validation
Testing and analytics
Evidenced

„Building on a long-standing history of expertise in the development and validation of analytical methods, we have the internal capabilities to conduct method development“

Source · 10 Nov 2026 ↗
External QP and batch certification
Release and quality
Evidenced

„Nuvisan offers batch release overseen by an EU-qualified person (QP). The QP services include batch certification of commercial products for European market release.“

Source · 10 Nov 2026 ↗
Contract research organisation (CRO)
Clinical research
Evidenced

„Nuvisan ist eine Full-Service-Auftragsforschungsorganisation (CRO) und Entwicklungs- sowie Produktionsorganisation (CDMO) mit hochmodernen Laboren in Deutschland und Frankreich.“

Source · 10 Nov 2026 ↗
Trial site management
Clinical research
Unclear

„Klinische Studien sind ein zentraler Bestandteil auf dem Weg zu neuen Medikamenten und Therapien. Mit deiner Teilnahme wirst du Teil eines wichtigen wissenschaftlichen Prozesses“

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_BY_04_MIA_2026_0083

Neu-Ulm

DE_NW_05_MIA_2024_0019

Waltrop

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_NW_06_GMP_2025_0005

Waltrop

DE_BY_04_GMP_2026_0128

Neu-Ulm

Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗

Sites

Wegenerstrasse 13
89231 Neu-Ulm

Headquarters

Im Wirrigen 25
45731 Waltrop