FDA gmp consultants

An Overview of GMP AND CGMP Guidelines

Because of the thalidomide tragedy in the U.S., the FDA (FOOD AND DRUG ADMINISTRATION introduced in 1940, GMP (GOOD MANUFACTURING PRACTICES). In 1963, the World Health Assembly supported CGM and stated that all companies, factories should follow GMP. In 1978, GMP was modified to CGMP and regulated by the FDA. CGMP works to ensure a…

Non-prescription Drugs

Facts about Non-prescription Drugs

Non-prescription drugs are commonly known as over the counter medicines (OTC). These drugs can be bought from a retailer without any prescription. FDA decides which treatments need a prescription and which can be purchased over the counter. Now let’s see the difference between prescription and non-prescription drugs. Prescription medicines are those which are safe and…

combination of drug product development

Facts About Combination Drug Products and Their Developments

Introduction: The diagnostic products, including drugs, devices, and biological products, are commonly referred to as Combination drug products. Combination products generally contain components that are typically regulated by different types of regulatory authorities. These products also face different kinds of challenges by various FDA centers regarding regulation, policy, and review management. The regulatory processes can…

Human factor and product combination of drug development

Human Factor And Product Combination Of Drug Development

In this development federation products are gathering pace, with lots of the worldwide pharmaceutical business raising them as a solution division of their latest product in the works. In various cases, firms clean off their elder drugs and produce new brain property around the newest rescue technology. New vaccination technologies, lesser combination pumps, and smarter…