Eurofins

Eurofins

Eurofins

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.

 

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, Austria, 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.

 

Eurofins Biopharma Product Testing’s service offerings include:

  • Raw Material Testing
  • Release Testing
  • Residuals & Impurities Testing
  • Stability Testing & Storage
  • Packaging Testing
  • Facility & Process Validation
  • Cell Banking Services

 

Eurofins CDMO is a leading global Contract Development and Manufacturing Organization (CDMO) that provides clients with Active Pharmaceutical Ingredients (“APIs”)/Drug Substance (DS) and Drug Product (DP) development for biologics and small molecules. We support small and major biopharmaceutical companies. Our sustainable and flexible methods help them achieve their pre-clinical and clinical milestones on time.

 

We are experts in breakthrough technologies for API development, highly potent compounds, poorly soluble drugs, lyophilization processes and specific therapeutic areas (immunotherapies, orphan drugs, pediatric dosage forms, etc.)

 

Involved in the earliest steps, our highly-qualified project management team will propose a complete drug development strategy in compliance with regulations.  Frequent communication through one single point of contact, our team's flexibility, troubleshooting mindset, customized solutions will help speed up the drug development process. Operating under strict quality procedures, Eurofins CDMO is accredited through the FDA, EMA, ANSM, ANSES, FAMHP, PMDA, and Health Canada.

 

Our goal is to build a sustainable partnership with our customers to support their drug development pathway.


Eurofins CDMO’s service offerings include: 

  • APIs/DS development
  • Solid state research & development
  • Pre-formulation, formulation development
  • Analytical development
  • Non-GMP & GMP manufacturing
  • Clinical packaging and logistics
  • Project management
  • CMC RA
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