Eurofins BioPharma Product Testing ENCO, Inc.
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Eurofins BioPharma Product Testing ENCO, Inc.?
Overview
Eurofins BioPharma Product Testing is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies.
Our service offerings are fully comprehensive and include testing of drug substance, final product, intermediates, and starting materials for both small and large molecule drug products. We give clients the flexibility to choose from three service models to meet specific project needs, including the award-winning PSS Insourcing Solutions® and we also provide secure 24-hour data access via our online data portal, LabAccess.com(sm).
Our laboratories offer a broad range of methodologies under GMP authorization, ISO 17025 accreditation and ISO 9000 certification and all analysis are performed according to European and British Pharmacopeia (EP and BP), United States Pharmacopeia (USP) and Japanese Pharmacopeia (JP), as well as specific customer methods. With a global capacity of more than 200,000 square meters and facilities located in Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, India, Ireland, Italy, Japan, Netherlands, New Zealand, Slovakia, Spain, Sweden, Switzerland, UK and the US, our network of GMP laboratories operates under the same strict quality procedures, LIMS and centralized billing system across more than 45 locations worldwide.
Standards & Methodologies
United States Pharmacopoeia (USP) (current)
European Pharmacopoeia (EP) (current)
Japanese Pharmacopoeia (JP) (current)
Client Methods
Internal Methods
Qualifications, Certifications, Accreditations & Licenses
Below is a list of certifications, accreditations and registrations currently in place at ENCO:
Jacksonville, FL Facility
- FDA / GDUFA Registration - FEI # 3006067100
- DEA Registration # RE0352005. Registered for Schedules II-V.
- FL Bureau of Pharmacy - Registration # 80 1069.
Cary, NC Facility
- FDA / GDUFA Registration - FEI # 3009827154
- NC Controlled Substances Registration NC-PE 0000 4347. Registered for NC Schedules II-VI
- DEA Registration # RE0414691. Registered for Schedules II-V.
Lab Gallery
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Industries Served
- Agrochemicals or Agrichemicals
- Antfiungals
- Anti-Bacterials
- Anti-Bacterials
- Anti-Microbials
- Antigens and Antibodies
- Antivirals
- Biochemicals
- Biomaterials
- Biopharmaceuticals
- Biosimiliars
- Biotechnology
- Cell Lines and Cell Cultures
- Chemicals
- Clinical Research
- Clinical Trials
- Coatings - Anti-Microbial
- Coatings - Medical
- Dietary Supplements and Nutraceuticals
- Disinfectants
- Disinfection and Sterilization Systems
- Food Additives
- Food Grade Lubricants
- Food Ingredients
- Food Supplements
- Life Sciences
- Medical Devices
- Medical Devices (Electrical)
- Medical Devices (Reusable)
- Medical Devices - Sterile
- Medical Disposables
- Medical Gases
- Medical Implants
- Medical Instruments
- Packaging (Sterile)
- Packaging - Child-Resistant
- Packaging - Closures
- Pharmaceutical
- Pharmaceutical - Pediatric
- Pharmaceutical - Active Pharmaceutical Ingredients (API)
- Pharmaceutical - Compounding
- Pharmaceutical - Over the Counter (OTC)
- Pharmaceutical - Small Molecules
- Pharmaceutical - Sterile
- Pharmaceutical Excipients
- Pharmaceuticals - Large Molecules
- Vaccines
- Woundcare
- Yeasts and Mold
Testing Types
- Assay Development
- Assay Development
- Assay Specificity
- Bacteria
- Bio Burden
- Bioanalysis
- Bioassay
- Bioburden
- Cleanability
- Cleaning Effectiveness
- cleaning efficacy
- Cleaning Process Validation
- clinical
- Clinical Research
- Clinical Trial (Phase I)
- Clinical Trial (Phase II)
- Clinical Trial (Phase III)
- Clinical Trial (Phase IV)
- Particle Identification
- Particle Size
- Particle Size Distribution
- Particle Sizing
- Particles
- Particulate Analysis
- Pharmaceuticals
- Preclinical
- Raw Material
- Related Substances
- Residue on Evaporation
- Residue on Ignition
- Residues
- Robustness
- Sterility
Publications
Eurofins BioPharma Product Testing ENCO, Inc. Registers with Contract Laboratory - The Laboratory Outsourcing Network! (Press Release)DISCLAIMER: This Laboratory Profile was provided by the company above.