Analysis & Release Testing

Our Biologics & Small Molecule Pharmaceutical Testing Center
in Waltrop

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NUVISAN Waltrop is one of our three GMP sites and excellence center for biopharmaceutical analysis and container closure integrity testing. In our GMP teams, we support your clinical and commercial pharmaceutical products with cGMP compliant processes and services – from method transfer and validation to release and stability testing.

Pharmaceutical Testing for Biomolecules

NUVISAN Waltrop provides a broad range of platform technologies for pharmaceutical antibody analytics, including Capillary Electrophoresis, Chromatographic Separation, Mass Spectrometry and ELISA.

 

Pharmaceutical Testing for Small Molecules

Building on a long standing history of expertise in the development and validation of analytical methods for small molecules, NUVISAN Waltrop still provides state of the art analytics for various formulations, e.g. tablets, powders, rings and implants.

Release testing, Stability Storage and testing

NUVISAN Waltrop is one of our main stability centers in Germany, and covers all standard ICH/VICH conditions as well as customized conditions for product specific applications, with varying temperatures and humidity settings. With our walk-in climate chambers, we support long-term studies from technical batches to market release batches.

Container Closure integrity testing

Container Closure Integrity (CCI) protects your product from leaking and microbial ingress. To determine CCI for various product containers and formulations, NUVISAN Waltrop has developed into an excellence center with state of the art techniques - including Blue Dye Ingression, High Voltage Leakage Detection, Frequency Modulation Spectroscopy for Headspace Oxygen and Carbon dioxide determination.

GMP certification

Certified by local and international authorities for Human and Veterinary medical Products, NUVISAN Waltrop supports clinical and commercial projects around the globe.

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NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management