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With more than 60 qualified scientists NUVISAN is one of the largest bioanalytical laboratories in Europe and supports requirements for analysis of parent molecule or metabolite, and endogenous compounds in biological matrices at all stages of product development.

 

Service Overview

• Bioanalytical capabilities to support the analysis of both large and
   small molecules

• Bioanalytical method development and validation following the most recent
   international guidelines

• Bioanalytical method adaption and cross-validation of existing methods

• Bioanalytical services for toxicology studies under full GLP compliance

• Bioanalytical support for all types of Phase I studies
   (FIM, PK, PD, Interaction etc.)

• Bioanalytical services to support large Phase II-IV multicenter studies 
   (>50000 samples; >3 years duration)

• Biomarkers

• Highly flexible transfer of bioanalytical data in different formats

• Customized reports (eCTD) to meet individual sponsor needs

 

YOUR BENEFIT

• Over 30 years of experience in Bioanalytics

• Well trained and highly motivated staff with an average of
   > 15 years of practical experience

• GLP certified since 1994

• Frequent inspections by clients and excellent regulatory standing with
   a variety of regulatory agencies, including EU, U.S.A. and Brazil.

• High flexibility for smaller sponsors and big pharma

• One face to the sponsor (personnel continuity)

• Low employee turnover (<3%)

 

METHOD DEVELOPMENT,
VALIDATION AND SAMPLE ANALYSIS

• Greater than 500 non proprietary methods developed and validated in
   a large variety of matrices (plasma, urine, feces, saliva, bile,
   semen, cerebrospinal fluid (CSF), and a variety of solid tissues)
   Validated Assay List

• Validation criteria follow FDA (May 2001), Workshop/Conference report
   of Crystal City (February 2007) and EMA 2011 guidelines

• Special expertise in steroid hormone analysis (LC/MSMS, GC/MS)

• Development, validation, and utilization of dried blood spot assays

• Experience in the development and validation of peptide assays
   via LC/MS/MS

• Special expertise in trace element analysis by ICP-MS, pioneer in
   elemental analysis as a CRO service: 15 years of quantitative
   analysis e.g. iodine, platinum, lithium

• Extensive experience in the analysis of organic nitrates (GC/MS)

• Special expertise in prostaglandin analyses (LC/MS/MS)

• In-depth experience in the analysis of biphosphonates (LC/MS/MS)

• Substantial bioanalytical expertise to support
   Biopharmaceutical Development (ELISA, RIA, Flowcytometry)

• Biomarkers

• Method Transfer, Adaptation, and Revalidation

• Cross Validation

• Protein-Binding

• Routine analysis of light-sensitive, unstable, or endogenous analytes

• Numerous assays with lower limits of quantification (LLOQ) between
   1.0 and 10.0 pg/mL

• Flexible organization of instruments and staff to include the capability
   to process large sample batches in a short time.

• > 250 000 samples analysed per year

• Approximately 300-400 projects per year from early toxicology phase
   and clinical phase I - IV studies

• A comprehensive sample logistics service with a dedicated logistics 
   manager is available to ensure the safe transit of frozen samples from
    investigator sites

 

QUALITY STANDARDS

• GLP certified since 1994 (German regulatory authorities)

• GCP – Good Clinical Practice

• Detailed internal audit program 

• License for handling narcotics

• ANVISA (Brazil) Inspected and Approved

• FDA (frequent BIMO inspections)

• Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit 
   (GLP, Local Agency)

• ZAB, Regierung von Oberbayern (GCP, local Agency)

• QM Service for Clients / Customers

• 100% internal QC check

• EMA reflection paper

 

FACILITY

• One of the largest bioanalytical single site laboratories in Europe

• 2500 m² lab space arranged over several floors, state of the art facility

• Temperature monitoring using Rees-system 24 hours a day and
   7 days a week

• Large capacity for storage at 5°C, -20°C and -70°C

• Validated CFR Part 11 compliant oracle-based Laboratory Data 
   Management System

Contact

Business Development
Please send us an Email!

 

 

Dr. Achim Freisleben
Vice President
Bioanalysis

Dr. Dwight D. Stiff
Vice President 
Business Development

Dr. Florian Schwaak
Director 
Business Development