SITE GRAFING

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The NUVISAN Pharmacokinetic Hub

Excellent Center for In vitro and In vivo DMPK, Isotope Chemistry and Discovery & Regulatory Bioanalysis.

Including a state oft the art Animal Housing, dedicated Equipment for radioactive Synthesis and sufficient Technologies for Bioanalysis of Small Molecules for Discovery and Development.

Infrastructure

Headcount: 53 (42% university graduates)
Lab Capacity: 1.200 m² Space

Animal Housing Capacity: 1.000 m²
Bioanalytical Capacity: 220 m²

Inspections & Authorizations

GLP certified (1990)
AAALAC Accreditation
License to work with radioactivity (14C, 3H) and genetically modified organisms (S1)

 

History

Established in 1965 and hold by Merck KGaA for Discovery and Development of DMPK
Acquisition from Merck KGaA in 2016
Today Grafing supports non-clinical in vitro and in vivo DMPK with Merck KGaA as partner

Working Fields & Specialties

In vitro & In vivo DMPK
Bioanalysis with respect to discovery and GLP bioanalysis with fast turnaround times
Metabolite Profiling and Identification
Radiosynthesis/Isotope Labelling & QWBA
Mass Spectometry with license to handle radioactivity: human mass balance studies can be supported

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Our Services & Solutions along
the Drug Development Value Chain

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Discovery

PRECLINICAL

Clinical Phase I

Clinical Phase II

Overall Services

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

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