Eurofins BioPharma Product Testing ENCO, Inc.

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Eurofins BioPharma Product Testing ENCO, Inc.


Profile

Lab Biography

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 analyses 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.

Qualifications

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.

We operate under a Quality System aligned with ISO 17025-2015.

Standards & Methodologies

United States Pharmacopoeia (USP) (current)
European Pharmacopoeia (EP) (current)
Japanese Pharmacopoeia (JP) (current)
Client Methods
Internal Methods

Industry Types Served

Biotechnology & Life Science Products, Medical Devices & Healthcare Products, Pharmaceuticals & Biopharmaceuticals

Lab Testing Types Offered

  • Bioassays & Functional Testing
  • Biology & Life Sciences
  • Biomarkers & Oncology Studies
  • Cell & Tissue Culture
  • Chemistry & Compound Analysis
  • Chromatography & Spectroscopy
  • Contaminants
  • Adulteration & Purity
  • Extractables
  • Leachables & Impurity Testing
  • Formulation
  • Deformulation & R&D
  • Immunology & Immunoassays
  • Molecular & Genetic Testing
  • Physicochemical & Materials Properties
  • Preclinical & Toxicology Studies
  • Proteomics & Protein Analysis

Location

Executive Park Court, Jacksonville, Duval County, Florida, United States

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