What is a Raw Material? A raw material is a basic material that is used to make a product. The formulation of each product, whether it be a drug, cosmetic/personal care product or dietary supplement is a unique combination of raw materials. Active ingredients, inactive ingredients, preservatives and processing aids
What is Toxicology? Toxicology is the science of poisons, including the effects of those deleterious substances on living organisms. In vivo toxicology is the branch of the science that investigates those effects using laboratory animals upon which testing is conducted. In contrast, in vitro toxicology is the branch of the
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
Regulatory Status of Cosmetics and Important Legal Concepts The Federal Food Drug and Cosmetic (FD&C) Act defines “cosmetic” products by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the
In order to assure the continuing availability of hand sanitizers throughout the COVID-19 pandemic, FDA issued a number of Temporary Guidance Documents aimed at increasing production of hand sanitizers by relaxing some of the basic requirements for OTC Drug products distributed within the USA. The major elements of FDA’s temporary policy for
Recent testing of numerous sunscreen products in US distribution has revealed significant levels of benzene in many of the products (mostly ‘aerosol’ products), with some even exceeding the current FDA limit of 2 parts per million (ppm). These findings (which were confirmed by one major US manufacturer’s internal testing of
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What is a Raw Material? A raw material is a basic material that is used to make a product. The formulation of each product, whether
What is Toxicology? Toxicology is the science of poisons, including the effects of those deleterious substances on living organisms. In vivo toxicology is the branch
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
Regulatory Status of Cosmetics and Important Legal Concepts The Federal Food Drug and Cosmetic (FD&C) Act defines “cosmetic” products by their intended use, as “articles
In order to assure the continuing availability of hand sanitizers throughout the COVID-19 pandemic, FDA issued a number of Temporary Guidance Documents aimed at increasing
Recent testing of numerous sunscreen products in US distribution has revealed significant levels of benzene in many of the products (mostly ‘aerosol’ products), with some
Corporate Headquarters and Labs
70 New Dutch Ln
Fairfield, NJ 07004
973-576-5957
Satellite Clinical Lab Location
304 Wootton St.
Boonton, NJ 07005
FDA
Registration FEI # 1000151293 as a GMP/GLP/GCP Drug Establishment and Cosmetic Facility.
DEA
Registration# RC0199744 (Analytical Lab)
Schedule I-V license
Remember, Schedules I-II require DEA Form 222
Registration# RC0171568 (Researcher)
US EPA/NJ DEP
Registration# NJD982726648
ISO/IEC 17025:2017 Accreditation # 80071
