DMPK & Isotope Chemistry Center

Our Non-Clinical Pharmacokinetic Hub in Grafing / Munich

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YOU WILL FIND NUVISAN’S PHARMACOKINETIC HUB NEAR MUNICH

Our facility is located in Grafing, approximately 30 kilometers east of Munich, Germany. Historically, the site was founded in the mid-sixties of the last century and was owned by the international pharmaceutical company as of 1967. For almost 50 years, it was the center of excellence in ‘Drug Metabolism and Pharmacokinetics’ (DMPK) before it was acquired by NUVISAN in 2016.

WE ARE COMMITTED TO HIGHEST SCIENTIFIC AND ETHICAL STANDARDS

The site in Grafing is GLP-certified (category 2, 8 and 9), licensed to work with radioactivity as well as genetically modified organisms (S1), and is equipped with state-of-the-art analytical instruments. Our team of more than 60 scientists and laboratory technicians is providing high-quality standardized or tailored DMPK services along the entire R&D value chain (<<links to In vivo DMPK and In vitro DMPK>>). Our cutting-edge and AAALAC-accredited animal facility allows the execution of the full panel of absorption, distribution, metabolism, and excretion (ADME) studies in rodent and non-rodent species according to the highest ethical and animal welfare standards, supplemented by a large variety of in vitro DMPK assays supporting the profiling of drug candidates. Accompanied by our capabilities in stable and radioactive  Isotope Chemistry, high-end mass spectrometry for small molecules (NCEs, SMOL) (<<link to Bioanalysis>>), and Support of PK Science, we  offer our clients a one-stop-solution in DMPK.

 

WE ARE MORE THAN SOLE SERVICE PROVIDERS

Due to our long-standing experience in DMPK, we understand that every project has its own individual requirements and that a ‘one-fits-all-solution’ is not always appropriate. Our experts take agile and consultative approaches and work towards the best strategy depending on your needs. We conduct fast turnover in vivo screening PK studies in drug discovery up to regulatory (e.g., IND/IMPD- enabling) assays as of drug candidate selection according to the highest industry standards and in full compliance with relevant guidelines from health authorities. We ensure data are delivered on time to meet your next project milestone or even to successfully attain market authorization.

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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