NJ Labs
One-Stop-Shop for Quality Analytical Testing

Every organization involved in scientific research or new drug development has various laboratory and testing needs. These needs include managing complex laboratory equipment and hiring expert personnel, as well as understanding various analytical testing capabilities and services with an in-depth knowledge of regulations and compliance. But in many scenarios, the manufacturing firms and organizations lack the capacity or the testing laboratory with the required equipment or skilled staff to execute the development and validation work. To address this challenge, organizations opt for outsourcing analytical services and reach out to contract laboratories to meet their project needs. Partnering with the right contract lab gives them a significant advantage in reducing the need for investing in heavy equipment or in-house analytical capabilities while leveraging the analytical services of the contract laboratory. However, drug manufacturing organizations must make the right choice. The contract analytical laboratory must provide the right resources and know-how to assist the organizations in navigating the complex requirements related to quality, compliance, budget, and timeframe. Finding the right laboratory while considering all these factors can be a cumbersome task.

Emerging as a savior in this context to address every testing challenge is NJ Labs, a full-service analytical chemistry and microbiology laboratory that focuses on testing quality. The company ensures that their clients meet each set of regulations to avoid the FDA’s chances of detecting deficiencies in their products. This significantly helps their clients be compliant and eliminates delays in submitting paperwork, recalls, late delivery of products, compromised reliability, or worse, consumer complaints. NJ Labs’ offerings extend beyond the testing services to reach out to the clients, customers, and manufacturers and build long-term partnerships and relationships with them. For instance, when manufacturers approach them, NJ Labs probes to understand their end goal; whether the clients want to manufacture and submit a drug to the FDA that can be delivered in the market for the next 20 years or if they want assistance in fulfilling certain deficiencies so that they can submit all the paperwork to the FDA. “We serve as a one-stop-shop that addresses clients’ testing needs to the best of our abilities and we go beyond testing by ensuring quality, transparency, and integrity in order to build a robust relationship with them,” mentions Sandra Baek Lee, CEO of NJ Labs.

NJ Labs possesses a wide array of testing capabilities for its diverse clientele. These include analytical chemical testing types like Elemental Analysis, Enzyme Activity, Vitamin Analysis, Amino Acids Analysis, as well as other types of testing. Further, the company showcases prolific flexibility in acquiring state-of-the-art instrumentations that bring several unique techniques into their portfolio, for example, High-Performance Thin Layer Chromatography (HPTLC) and ICP-MS, to name a few. NJ Labs is also FDA, DEA, registered and inspected, entrusted with handling controlled substances and helping cannabis companies introduce their products into the market for several years. To ensure this, they dedicated immense efforts to upgrade their technologies and laboratories to enhance their quality management system(QMS).

The steering force for unlocking diverse capabilities is its dedicated team. Be it the bench chemists or microbiologists, they go beyond their skillsets and expand their capabilities to ensure that clients meet their desired objectives. Further, they prioritize completing the tasks with a good response time, proper structure and traceability, and good science and testing experience backing it to best meet the client’s needs. Additionally, the team offers consultations and advice that complement the services, helping the clients understand the tests and their results efficiently.

We serve as a one-stop-shop that addresses client’s testing needs to the best of our abilities and we go beyond testing by ensuring quality, transparency, and integrity in order to build a robust relationship with them

NJ Labs’ QMS also ensures robust communication and commendable response time with improved quality, accuracy, and testing precision. This holistic suite of services also assists clients in eliminating the need to go to different companies and laboratories for testing, quality assurance, and related work. “We’re a one-stop-shop where we have a micro lab and a chemistry team that are capable of trying to meet all our clients’ needs and they work as an extension of the manufacturer’s quality departments,” adds Sandra.

NJ Labs primarily follows United States Pharmacopeia procedures. The company also devises custom-tailored methods to provide better quality products for clients and reduce recalls and complaints while enhancing the accuracy of the testing results. Besides, the procedures comply with the USP guidelines, and are tested under multiple environments and conditions. Moreover, NJ Labs has proved robustness where if different people run the tests on different instruments, they would render almost consistent results. A critical element that helps them achieve this is their collection of data that helps determine the variation of results based on the behavior with alternate methods.

The CEO mentioned a couple of instances that illustrate the flexibility of the methodologies offered by NJ Labs. For example, in some instances, when they do not have a specific method, the client obtains it from the manufacturer. But in most cases, the methods are incomplete as precision or accuracy were not demonstrated appropriately. However, such aspects are essential to ensure that the testing delivers accurate results in the long run too. So here, NJ Labs evaluates it, identifies the parts that can work well, or detects the missing parts that make the overall method good and helps its clients understand what to expect.

Substantiating on their capabilities, Sandra discussed a client who wished to manufacture a drug that required a laboratory which could handle controlled substances. This client required significant testing for the impurities that included methamphetamine. To accomplish this project, they had opted to work with NJ Labs to help them successfully submit the NDA to the FDA within a period of six months. The NJ Labs team made this possible with their unparalleled efforts and dedication, working tirelessly for countless hours and sacrificing time with their families. NJ Labs was able to start working within 24 hours and assisted with testing the commercial batches. They rewrote and modified their protocol to better fit the client’s needs. Eventually, they were able to submit it to the FDA for approval. NJ Lab’s ability to provide all the required data, documents, chromatograms, re-analysis or revision of protocols and reports, and the overall transparency needed to meet the FDA requirements facilitated this client to complete their project seamlessly.

NJ Labs has also invested efforts in internally growing the company for strengthening its suite of services. They focus on management training and improving communications with the employees to assure their satisfaction in working with the company. “We go through great efforts to listen to our employees and let their voices be heard,” mentions Sandra.

NJ Labs is looking forward to expanding its geographical presence in the near future. Additionally, they are keen on entrenching further into the cannabis sector beyond testing by helping facilitate standards for cannabis, related products and the quality procedures surrounding this emerging market. They are also working on becoming ISO 9001 certified. This will enable the cultivators of these plants and the manufacturers of the related products to reach out to NJ Labs to meet their testing requirements and receive their desired quality of products for the required tests. Therefore, NJ Labs’ efforts aren’t constricted just to the client’s needs but have a significant contribution in protecting public health by offering the right quality product.