In Eurofins, the pharmaceutical industry has a reliable laboratory partner to collaborate in drug development and quality control. We provide bioanalytical and global safety testing worldwide for clinical research programs. Globally, we work with several of the top 10 pharmaceutical companies and serve many smaller pharma and biotechnology organizations as well as CROs and phase 1 units.

Here in the US, we have several locations decicated to first rate pharmaceutical testing, and their combined capabilities provide the industry with an unmatched and comprehensive portfolio of services.

Eurofins Avtech Laboratories, Inc.

Eurofins AvTech is an analytical Contract Research Organization (CRO) serving the pharmaceutical industry since 1990. We provide clients with peace of mind through our scientific excellence and exemplary client and FDA audit record, especially when they are facing difficult analytical challenges or adverse regulatory issues. We specialize in the development, validation, and routine performance of GxP-compliant methods for all stages of drug discovery and development from early ADME studies, to stability and release testing of the finished product. Available technologies include HPLC, GC, GC-MS, LC-MS, and immunoassay. Available services include:

• GMP method development and validation
• GMP product testing
• Pre-clinical and clinical bioanalysis
• Biomarker detection and quantitation
• Animal health product testing

For more information on our services, please visit us at www.avtechlabs.com.

Eurofins Medinet

Eurofins Medinet is a wholly owned subsidiary of Eurofins Scientific, a global organization fully focused on global central laboratory testing to support clinical trials for the pharmaceutical and healthcare industries. Services include:

• Global central laboratory testing services, supported by safety (chemical, hematological and immunological analysis) laboratory testing, project & data management, logistics & courier management, Quality Systems, regulatory compliance, global SOPs
• Anti-Infective Services, including specialty testing, antimicrobial surveillance, consulting
• Bio-analytical testing to support pharmaceutical products and their metabolites in different matrices
• Genomics, Biomarkers, PK

Eurofins Medinet is also a leading provider of complete anti-infective laboratory and consultative services to the biopharmaceutical industry in support of all phases of anti-infective drug development and commercialization. Anti-infective services include:

• Microbiology testing to support clinical trials
  • Dedicated, full-service microbiology laboratory, international quality standards, expert mycology and bacteriology testing; globally recognized capabilities to support clinical trials for all indications; fully supported by other key global services – safety laboratory testing, project & data management, logistics, Quality Systems, regulatory compliance, global SOPs
• Antimicrobial surveillance
  • Eurofins Medinet owns and manages the world’s largest repository of current, characterized and clinically relevant bacterial pathogens
  • The Surveillance Network (TSN) is an electronic antimicrobial surveillance database that contains strain-specific, qualitative, and quantitative antimicrobial resistance test results to evaluate resistance patterns
• Specialty microbiology testing required by US FDA to characterize new drugs:
  • Molecular Characterization (PCR, Sequencing)
  • Molecular Typing (PFGE, Ribotyping)
  • Lead Compound Screening
  • Resistance Development
  • Bactericidal Activities (Timekill)
  • Synergy/Antagonism
  • Post-Antibiotic Effect
  • Development of Disk Diffusion and MIC Methodologies
  • Quality Control Range Development
  • Interpretive Breakpoint Determinations

Eurofins Medinet owns and operates state of the art laboratory testing facilities in Breda, the Netherlands, Paris, Washington DC, Denver USA, Singapore, and Shanghai.

To obtain additional informational on our services, please visit us at www.eurofins-medinet.com.

Eurofins Products Safety Labs

Since 1974, Eurofins Product Safety Labs (EPSL) has been providing technically excellent and GLP- compliant preclinical and bioanalytical test services to the pharmaceutical and biotech industries...Services include:

1. GLP acute and subchronic mammalian toxicology for IND submission. GLP analytical test services available for dose analysis and method transfer, development and validation. PK/TK services with bioanalytical testing and method development also available upon request.
2. In-vivo Pharmacology-Wide experience in developing and using many animal models to evaluate product/prototype efficacy. Mostly non-GLP, but can be conducted under GLP if desired. Regularly conducting studies on inflammation, cardiovascular devices and pharmaceuticals, pain and metabolic diseases (e.g., diabetes, obesity, hyperlipidemia.
3. Pharmacokinetics-all species from rodents to swine and primates. We provide results quickly to expedite your drug development efforts.
4. Bioanalytical-Experienced scientific team. Can support preclinical and clinical studies.

You can find more detailed information on our capabilities and some prices at www.productsafetylabs.com.