Regulatory Compliance
New Jersey Laboratories has been registered and inspected by the FDA since 1978. The Food and Drug Administration (FDA) regulates the conduct of non-clinical laboratory studies under Part 58 (Good Laboratory Practice for Non-clinical Laboratory Studies) of Title 21 of the Code of Federal Regulations. All analyses performed in our laboratory meet strict compliance as described in these current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (cGLP).

The principles of GLP are designed to ensure that laboratory testing and results are of a good quality and are traceable. cGMP and cGLP regulations support accountability via documentation and aim to keep quality and integrity in the forefront of all product testing. cGLP helps assure regulatory authorities that data produced are an accurate reflection of the actual testing performed and therefore can be relied on when making safety assessments.

All testing facilities must have written standard operating procedures in place to define the methods utilized in the laboratory. Written rules are critical to ensure the quality and integrity of the data obtained. NJ Laboratories maintains a library of SOPs (Standard Operating Procedures) that meet the cGLP and cGMP requirements.

The Quality Assurance Unit inspects data generated by the laboratory to ensure that these analyses comply with all applicable regulations. NJ Labs also has a comprehensive instrument calibration system to ensure that all instrumentation used in support of these studies is fully qualified.
New Jersey Laboratories
Registered by:
United States Food and Drug Administration (FDA)
Drug Enforcement Administration (DEA)
New Jersey Controlled Substance
Contact Information:
Sandy Lee (General Manager) | Email: info@njlabs.com

1110 Somerset Street
New Brunswick, NJ 08901
Before calling - Please go to NJ Labs Tick Test regarding tick information.
Phone: 732-249-0148
Fax: 732-249-0243


Business Hours:
Monday - Friday 8:00 AM - 4:30 PM
Closed Sat and Sun

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