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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.
  • Customized solutions tailored to your project needs and budget.
  • Process control and quality assurance. Period.

Current registration

  • ISO 9001:2008
  • ISO 13485:2003
  • FDA 3009882691 for the manufacture of ASRs (Analyte Specific Reagents) for use in IVD products

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.


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.

Applications

Industries

Clinical tests for Companion Dx

Pharmaceutical Drug Development

510K IVD Diagnostics

Healthcare

Analyte Specific Reagents for:

Contract Research Organizations

- Standard PCR

Commercial IVD Companies

- Specialty PCR

Testing

- Sequencing

Consumer Products

Next-Generation Sequencing

Medical Genetics Testing

Microarrays

Forensics