Antibiotic Potency Testing in Pharmaceuticals Antibiotic potency testing plays a pivotal role in the pharmaceutical industry, ensuring that antibiotic products are both effective and safe for consumer use. As antibiotics are critical tools in combating bacterial infections, maintaining their efficacy is essential to public health. Potency testing verifies that these
The Importance of Microbial Content Testing in Non-Sterile Products Ensuring the safety and quality of non-sterile products is paramount. These products, which range from pharmaceuticals to cosmetics, are integral to everyday life. However, their non-sterile nature means they can potentially harbor harmful microorganisms. This is where microbial content testing becomes
The Role of Ames Mutagenicity Testing in Product Safety Ames mutagenicity testing is a technique in product safety that is pivotal for identifying potential genetic mutations caused by chemical substances. This test is integral for manufacturers across various industries, from cosmetics to pharmaceuticals, to ensure that their products do not
Low-Level Detection in Modern Product Safety Product safety is crucial for manufacturers and consumers in today’s fast-paced consumer market. With the increasing complexity of product formulations and stringent safety regulations, identifying potential contaminants at low concentrations has become more critical than ever before. Low-level detection testing is vital in this
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of benzene in aerosol OTC Sunscreen products, which resulted in high-profile product recalls in 2021. One might argue that chemical contaminants have always been present in
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of benzene in aerosol OTC Sunscreen products, which resulted in high-profile product recalls in 2021. One might argue that chemical contaminants have always been present in
Each of the following topics will be discussed over the course of this three-part article exploring Drug Product Contaminants: Definition of a Drug Product Contaminant Types of Contaminants that are Found in Drug Products Classification of Drug Product Chemical Contaminants and their Sources API Impurities Extractables And Leachables Supply Chain
Regulatory Status of Over-The-Counter (OTC) Drugs OTC Drug products (also referred to as ‘Nonprescription Drugs’) are defined by FDA as “drugs that are safe and effective for use by the general public without seeking treatment by a health professional.” With only a few exceptions, OTC Drugs may be launched in
Understanding method validation vs. verification is vital when trying to launch your next regulated product. When testing regulated products such as Pharmaceuticals (Prescription and Over-the-counter), Medical Devices, Dietary Supplements or even Cosmetics, the test methods employed must meet certain performance requirements or the results obtained from using the methods will
The Food & Drug Administration (FDA) has a standardized set of principles that ensure the safety and consistency of pharmaceutical and cosmetic products. Being compliant with the FDA means that products are safe to use and properly labeled. FDA compliance isn’t something that should be overlooked or taken lightly. Otherwise,
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Antibiotic Potency Testing in Pharmaceuticals Antibiotic potency testing plays a pivotal role in the pharmaceutical industry, ensuring that antibiotic products are both effective and safe
The Importance of Microbial Content Testing in Non-Sterile Products Ensuring the safety and quality of non-sterile products is paramount. These products, which range from pharmaceuticals
The Role of Ames Mutagenicity Testing in Product Safety Ames mutagenicity testing is a technique in product safety that is pivotal for identifying potential genetic
Low-Level Detection in Modern Product Safety Product safety is crucial for manufacturers and consumers in today’s fast-paced consumer market. With the increasing complexity of product
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of
There have been growing concerns over the increasing number of chemical contaminants being found in today’s drug products. A recent example was the discovery of
Each of the following topics will be discussed over the course of this three-part article exploring Drug Product Contaminants: Definition of a Drug Product Contaminant
Regulatory Status of Over-The-Counter (OTC) Drugs OTC Drug products (also referred to as ‘Nonprescription Drugs’) are defined by FDA as “drugs that are safe and
Understanding method validation vs. verification is vital when trying to launch your next regulated product. When testing regulated products such as Pharmaceuticals (Prescription and Over-the-counter),
The Food & Drug Administration (FDA) has a standardized set of principles that ensure the safety and consistency of pharmaceutical and cosmetic products. Being compliant
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