Eurofins BioPharma Product Testing in USA

Eurofins Lancaster Laboratories, LLC

With 60 years of delivering comprehensive laboratory services, Eurofins Lancaster Laboratories, LLC enables global pharmaceutical and biopharmaceutical companies advance candidates from development through commercialization while ensuring regulatory compliance, cost effectiveness and achievement of timelines. For a seamless service experience, customers team with scientists and project managers throughout the outsourcing process from testing to monthly reports to 24-hour online data access at LabAccess.com^SM.

Accreditations/Certifications/Registrations:

• GMP compliant
• FDA audited
• EMA Certificate
• DEA
• HCT/P

Eurofins Lancaster Laboratories, LLC

Eurofins Lancaster Laboratories, LLC is an analytical Contract Research Organization (CRO) serving the pharmaceutical industry since 1990. Formerly AvTech Labs, this site became a part of Eurofins Lancaster Laboratories in 2012, allowing for a consolidation of the best practices of both laboratories in smooth workflow and regulatory compliance.

 Accreditations/Certifications/Registrations:

• GMP compliant
• FDA audited
• DEA

Eurofins Advantar Laboratories, LLC

Eurofins Advantar Laboratories, LLC provides analytical and formulation development expertise with respect to virtually all dosage forms and API’s ranging from small molecules (organic and inorganic) to peptides, proteins, DNAs and RNAs. Our GLP and cGMP-compliant lab services encompass Toxicology Test Article preparation and testing, Pre-formulation, Formulation Development, Analytical Method Development & Validation, QC release and stability, Clinical Trial Material Labeling/Packaging/Logistics and Regulatory/Technical Consultancy. Eurofins Advantar Laboratories has also added 1,500 ft² of non-sterile manufacturing capabilities.

Accreditations/Certifications/Registrations:

• FDA audited
• GLP

Eurofins BioPharma Product Testing Columbia, LLC

Eurofins BioPharma Product Testing Columbia, LLC (formerly known as EAG Laboratories) offers the pharmaceutical industry an analytically focused CRO with deep experience in method development, program design and complex study execution. A true development CRO, we deliver comprehensive CMC analytical support including multi-disciplinary, multi-technique analytical method development and validation, complete stability program management and in-depth extractables and leachables expertise—plus in-house custom synthesis and cGMP radiolabeling services. Eurofins BioPharma Product Testing Columbia also offers specialized materials testing to support supply chain and packaging initiatives, and the full range of environmental fate, metabolism and toxicology studies required to evaluate a pharmaceutical’s potential environmental impact. 

TECHNICAL SERVICES

• Method development and validation (drug and drug product)
• Stability testing and storage
• Protein characterization
• Bioassays and cell-based potency assays
• Dose formulation testing
• Extractables and leachables programs
• Container/closure qualification
• Impurity isolation, ID and characterization
• Reference standard synthesis, characterization and storage
• QC/release testing
• Custom synthesis and radiolabeling (including cGMP)
• Environmental risk assessments
• Specialized materials testing and failure analysis

Eurofins Human Factors MD, LLC

Founded in 2001, Eurofins Human Factors MD, LLC is the preeminent expert in human factors testing and analysis for pharmaceutical and medical device companies. The team has conducted tested human factors tests on a variety of products including combination projects like injection devices and inhalers and medical devices like ventilators, ultrasound, infusion pumps, and many more. Their unique expertise has assisted many companies in the testing of products and facilitated successful regulatory submissions.

The lab is in Charlotte, NC, and features three session and adjoining observation rooms. With state-of-the-art video equipment and the ability to simulate any testing environment, Eurofins Human Factors MD, LLC provides a best-in-class experience.

Testing and Analysis Services:

• Formative Usability Studies
• Human Factors Validation Testing
• Summative Testing
• Comparative Use Testing
• Threshold Analyses
• Heuristic Analyses
• Competitive Benchmarking
• Ergonomic Testing

Eurofins BioPharma Product Testing ENCO, LLC

Eurofins BioPharma Product Testing's  Jacksonville, Florida facility serves as the corporate headquarters for ENCO where we currently occupy 8,800 ft² of space with capacity to significantly expand.

This facility houses a wide variety of state-of-the-art instrumentation and equipment including the following:

Chromatography

• HPLC (UV, PDA, ELSD, RI)
• GC (FID, TCD, Head Space- residual solvent analysis)

Spectroscopy

• HPLC/MS/MS
• GC/MS

UV/vis spectrophotometer

FTIR with μATR

Refractometer

Viscometers

Rheometers

Dissolution

DSC

Accreditations/Certifications/Registrations:

• FDA-audited
• DEA-registered
• FL Bureau of Pharmacy

Eurofins BioPharma Product Testing ENCO, LLC

Eurofins BioPharma Product Testing ENCO, LLC in Cary, NC offers a wide variety of analytical services. It also serves as ENCO’s primary site for stability studies. Our Cary location currently occupies 4,400 ft² of laboratory space following its recent expansion.

There are multiple walk-in and reach-in chambers, all programmable to meet ICH conditions.

Stability Chamber conformance is monitored by a Vaisala viewlinc™ system. This industry leading system combines precise monitoring with effective alarming, easy reporting and secure data collection for improved productivity and operating efficiency while providing integrated monitoring.

Critical equipment, including all stability chambers, are supported by a natural gas powered back-up generator to ensure continuous power in the unlikely event of a loss of primary power. Other redundant back-up systems are in place to make certain that your samples are not compromised.

This location also houses a wide variety of state-of-the-art instrumentation and equipment, including:

Chromatography

• HPLC (UV, PDA, ELSD)

UV/vis spectrophotometer

Osmometer

KF Coulometer

Viscometers

Dissolution

Accreditations/Certifications/Registrations:

• FDA-audited
• DEA-registered
• NC Controlled Substances Registration