Purpose and Mission
Bionique® Testing Laboratories, Inc. will provide to all clients the best possible mycoplasmal testing products and services available to meet each clients individual quality standards. We will continue to be the recognized leader in mycoplasmal testing.
Core Values
Bionique® Testing Laboratories, Inc. supports the following set of core values:
Commitment to the highest ethical and professional standards.
Commitment to a climate of trust and respect for all employees.
Commitment to respect and cooperation with all clients, suppliers, and regulatory personnel.
Commitment to providing the very best in products and services.
Commitment to deliver what we promise.
Commitment to sustainable and profitable growth.
Commitment to being a good neighbor in the community.
Commitment to operating responsibly within the Adirondack Park.
Audits
Bionique® Testing Laboratories welcomes client audits since we are an extension of your quality program. It is our opportunity to demonstrate to you - the excellence of our staff, facilities and quality systems. Bionique® Testing Laboratories is committed to providing our clients with the very best in products and services - we value our clients’ experience and expertise.
Confidentiality
All client information including sample receipt, raw data and final reports are treated in strict confidence. When requested, Bionique® Testing Laboratories Inc. will work with individual clients to generate formal, contractual service and confidentiality agreements.
Pricing
Bionique® Testing
Laboratories quantity discount policy is linked to the number of samples
submitted as a batch on the same day, for the same test/catalog number
(M-100, M-175, M-500 & M-900 are excluded) and invoiced to the same purchase
order number. A 5% discount is offered for 5 to 9 samples and a 10% discount
for 10 or more samples received together for the same test with the same
P.O. #. This discount policy does not apply to samples which require
additional sample preparation prior to testing.
Quality
Assurance
All clients, submitting samples to Bionique® Testing Laboratories, can
be assured that we adhere to the highest standards for QA and QC activities
with regard to your samples.
Bionique® Testing Laboratories provides
a variety of mycoplasmal testing services compliant with CGMP standards
(Current Good Manufacturing Practices) Federal Regulations 21 parts 210
and 211. Bionique® Testing Laboratories’ registration number with the
Food and Drug Administration (FDA) is 1318709.
Reporting
Bionique® Testing Laboratories has the fastest possible turn around time for reporting in the industry. Clients receive written hard copies of all test results via first class mail provided by the United States Postal Service. If requested, final reports can be faxed, but we do not report by e-mail. Overnight courier service can be arranged at the client’s expense.
A Final Report package is assembled on the day that testing is completed, barring company holidays and unprecedented events. The Final Report package includes a copy of each final report document that has been reviewed for accuracy and completion. Each final report document has appropriate sign off in the form of date and initials or full signature. A Quality Assurance Report with review date and full signature is issued at the completion of testing for each of the following procedures: Test/Catalog #'s M-200, M-250, M-300, M-350, M-700, & M-800. Raw data and reports are archived and maintained by the Quality Assurance Department for a minimum of seven years.
Services
Bionique® Testing Laboratories, Inc. is committed to providing our clients with the very best in products and services. In addition to testing for mycoplasma, we offer contractual services to meet client specific needs in our areas of expertise – mycoplasma and cell culture. These services may include antigen production, consulting, education, research and development projects, training, and validation studies.
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