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ChRi Laboratories is a contract laboratory that delivers high quality analytical solutions for pharmaceutical, biotechnology, nutrition, and clinical research organizations worldwide. Our mission is to provide analytical services to help our customers deliver safe and effective products to improve lives. We are described by our clients as a team that delivers leading-edge scientific solutions that are based on real data-driven decisions. ChRi helps start your journey off stronger with our long tenure of experience in each phase of product development, from drug discovery to release testing. From test method development, validation, specifications, to writing justifications ChRi has also developed a more efficient process to conduct studies under stringent timelines. We have built our mission around the concept that collaboration and constant communication with our clients is the number one key to achieving the client's goal. Working alongside our clients, we are determined to understand the active ingredient(s), excipients, and the proper storage to study possible behaviors under stress to select the best condition for each method. ChRi Labs support pre-formulation studies, stability testing, raw materials and in-process testing, drug substance, and drug product characterizations. The laboratories are monitored continuously for temperature and humidity controls. ChRi operates under a FDA GxP (cGMP, GLP, GCP, and cGLP) Quality System that is managed by our Independent Quality Assurance Team. Our operations always meet requirements for ISO 17025 compliance.

Technical Information:

We provide testing services for Pharma/Biopharma, Drug-Device, Bio-functional Food Ingredients, and Nutraceutical Companies. Our cGMP analytical services include, chromatographic techniques (UPLC/UV-PDA, GC-MS) for Method Development, Validation, and Sample Testing such as assay and related substances, content uniformity, residual solvent analysis, cleaning protocols, bioanalytical assays, peptide mapping, and compendia method verifications.  We also provide Elisa and Biomarker assays, Yeast Beta Glucan Assays, FTIR-ATR Analysis, UV-VIS, pH Testing, Loss-on-drying, Karl Fisher Moisture Content Analysis, SDS-PAGE Electrophoresis, and several "bench top" methods. Examples of our current Product Development experience include Suppositories, Oncology protein formulations, oligonucleotide nanocapsules, topical creams, Solution formulations, coated anti-microbial device, metered-dose Inhalers, prenatal vitamin capsules, gummies, and Bio-functional foods and beverages.  We have experience in managing large metabolic disease studies. We also utilize validated in-vitro diagnostic assays for full Chemistry Panels, Hematology, Coagulation, Urinalysis, Immunology, Infectious Diseases, Drugs of Abuse, and Biomarker Assays. All testing are performed under cGMP procedures as listed below:

Key cGMP Analytical Processes:

  • Handling client requests and test orders
  • Equipment qualification, calibration, and "time-of-use" verifications
  • Reference standard program
  • Handling reagents, standards, buffers, and solutions
  • Quality control monitoring
  • Method development, validation, and qualification
  • Room and refrigerated systems monitoring
  • Sample receipt, inspection and chain of custody
  • Product development testing
  • Sample receipt, inspection, and chain of custody 
  • Product development testing
  • QC release testing
  • Purchased supplies inventory
  • Labeling
  • Sample retention program 
  • Stability program
  • GMP material receipt and sampling
  • GMP Documentation
  • Data Review and Reporting
  • Document Retention
  • Health and safety procedures 
  • Employee Training Program
  • Lab Investigations 
  • Business continuity/disaster recovery program

6128106010

651 340 1619

 Company Website

1000 Westgate Drive, Suite 40

Saint Paul, Minnesota 55114 US

DISCLAIMER: This Laboratory Profile was provided by the company above.