Eurofins is a highly-certified manufacturer of premium quality in vitro oligonucleotides for IVD and ASR applications within the clinical, pharmaceutical, food safety, and animal health industries. We provide custom solutions through a replicable system that meets regulatory standards and exceeds customer expectations.
Overview of Benefits
- Guaranteed deliverable that fully meets your regulatory requirements.
- Guaranteed yield based on customer specifications.
- All scales available
- Customized solutions tailored to your project needs and budget.
- Process control and quality assurance. Period.
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Current registration
- ISO 9001
- ISO 13485
- FDA 3009882691 for the manufacture of ASRs (Analyte Specific Reagents) for use in IVD products
- CLIA
- CAP
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Contact a Consultant
Due to the level of customization for each cGMP product, pricing is based on the unique needs of each client. Please contact our cGMP experts (below) to schedule a quick consultation session to outline your specific scope and project requirements.
cGMP Contact
cGMP Account Manager
Once the request is received, our experts will respond within 1 business day to begin discussions as to project requirements and to determine other genomic service needs.
Standard Delivery Times
We work hard to meet your deadlines so all projects remains on schedule and within budget. Delivered products and documentation will be customized according to the needs and requirements of the customer.
Unique Benefits
Eurofins is a global leader for a wide range of products and services including cGMP manufacturing, which enables us to provide unique product offerings and solutions within highly standardized process controls. In addition, we are the only company capable of supporting cGMP ASRs manufacturing and testing through orthogonal or intended use genomic platforms.
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Logical, Creative Solutions
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We offer a full pipeline of personalized services from research to commercialization where clients can benefit from customized low cost small scale synthesis for the development, carry out pilots, and ramp up to commercial scale production.
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Total Product Quality Support
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Established cGMP, cGLP, ISO planning structure supporting the manufacturing of cGMP oligonucleotides as well as additional genomic services for development, quality control, and validation of performance.
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Customer-Centric Customization
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Single point of contact for managing the cGMP projects.
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Measureable Business Impact
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Maximization of cost management through fair and flexible pricing arrangements based on milestones achieved through effective planning and execution.
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cGMP custom solutions for clinical, pharmaceutical, food safety and animal health industries
Already a global leader for a wide range of genomics products and services, Eurofins Genomics expanded into cGMP in order to support all of its customers’ needs from pilot projects through manufacturing of small to large-scale cGMP oligonucleotides. Below is a list of the most common industries utilizing cGMP and areas of application for cGMP oligonucleotides.
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Applications
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Industries
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Clinical tests for Companion Dx
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Pharmaceutical Drug Development
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510K IVD Diagnostics
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Healthcare
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Analyte Specific Reagents for:
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Contract Research Organizations
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- Standard PCR
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Commercial IVD Companies
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- Specialty PCR
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Testing
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- Sequencing
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Consumer Products
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Next-Generation Sequencing
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Medical Genetics Testing
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Microarrays
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Forensics
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