Contract Manufacturing

Your Complete Contract Manufacturing Solution

  • Extensive experience in OEM and Contract Manufacturing
  • Market-ready products are manufactured to the highest industry standards
  • ISO 9001:2015 and ISO 13485:2016 registered company
  • State-of-the-art, GMP compliant facilities
  • Conversion of R&D outputs into full product specifications including BOMs and packaging
  • Manufacturing of all solutions and buffers, sourcing of all other required components
  • Development of quality control procedures and strict release criteria
  • ISO Class 7 certified cleanroom for liquid filling capabilities down to Class 4
  • Filamatic liquid filling machine for high throughput filling

Norgen Biotek has tremendous expertise in OEM and Contract Manufacturing of kits and reagents for the molecular biology and diagnostics markets. We currently manufacture OEM products for numerous companies worldwide, both small and large, on a continual basis. These companies are various sizes from small to large global companies. Norgen is an ISO 9001:2015 and ISO 13485:2016 registered company with an excellent Quality Management System and we follow strict SOPs for production and QC. Norgen operates in a 32,000 square foot facility with full development labs and dedicated manufacturing quarters that are maintained according to ISO and GMP requirements. We have an ISO Class 7 certified clean room housing an ISO Class 5 certified Filamatic liquid filling machine. The clean room is routinely monitored for viable airborne contamination, viable contamination on surfaces and non-viable airborne contamination to maintain the ISO classification of the clean room environment. Within our clean room we have high throughput liquid handling capabilities that would meet any job size, and we have validated liquid filling protocols for all types of bottle sizes. With our Filamatic liquid filling machine we are able to perform high throughput liquid filling and capping of bottles ranging in size from 0.1 mL to 500 mL with a ± 0.5% accuracy. Our Filamatic machine can be used to fill low, moderate and high viscosity fluids, making this a very versatile service for the biotechnology and pharmaceutical industry.

Norgen will meet all of your requirements from concept to product with our extensive experience in product development and manufacturing.

Our Guarantee

Norgen’s manufacturing services will ensure that you have a complete product that will be ready to be brought to market in a rapid and cost effective manner. Let Norgen’s experience and expertise save you time, money and frustrations as we help you to productize your idea.

With Norgen’s contract manufacturing services we offer:

  1. Development of laboratory procedures into standardized SOPs and product inserts / instructions for use (IFU)
  2. Conversion of R&D outputs into optimized product specifications, including kit contents
  3. Development of Bill of Materials (BOM)
  4. Procurement of all required chemicals and components, as well as supplier qualification
  5. Development of SOPs for manufacturing of all solutions and buffers
  6. Development of Quality Control procedures for all solutions and buffers
  7. Formulating solutions and buffers according to SOPs
  8. Filling of solutions and buffers in our Class 7 certified cleanroom with capabilities down to Class 4
  9. Development of Quality Control procedures for the final QC and release of the finished product
  10. Design and procurement of product packaging, including art work and all product labels
  11. Maintenance of batch records for full traceability to meet industry standards

We Deliver Quality Products:

Norgen’s manufacturing services will be catered to each individual’s needs. Deliverables may include:

  • SOPs;
  • QC documents;
  • Product specifications;
  • Completed products manufactured and filled to the highest standards;
  • Product packaging and literature.

Please contact us in order to discuss your requirements and how Norgen can assist you.

Toll Free: 1.866-667-4362
Tel: 1.905.227.8848
Fax: 1.905.227.1061

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Learn more and inquire about Norgen Biotek's complete contract manufacturing solutions