NDA and ANDA
Understanding NDA and ANDA in the Pharmaceutical Industry The pharmaceutical industry is tightly regulated to ensure the safety, efficacy and quality of drugs. Two critical processes that facilitate the approval…
Safety and efficacy of the drug
Safety and Efficiency of Active Pharmaceutical Ingredients: A Critical Examination The active pharmaceutical ingredient (API) is the key component in any drug responsible for its therapeutic effects. Ensuring the safety…
Quality by Design
Quality by Design (QbD) in the Pharmaceutical Industry The pharmaceutical industry is governed by stringent regulatory requirements to ensure the safety, efficacy and quality of medicines. One transformative approach to…
Impurity profile-API
Types of Impurity Profiling of Drug Substances: Introduction: Impurity profiling is a critical aspect of pharmaceutical quality control that ensures the safety, efficacy and quality of drug substances and drug…
Intellectual Property management (IPM)
Intellectual property (IP) management is crucial in the pharmaceutical industry because it helps protect the significant investments made in drug development, encourages innovation and provides incentives for companies to continue…
Regulatory Aspects in Pharma Industry
In the pharmaceutical industry, regulation plays a critical role in ensuring that medications are safe, effective and of high quality before they reach the market. Here are the key regulatory…
API Process Development
The process development of an Active Pharmaceutical Ingredient (API) involves several key stages designed to ensure the compound is manufactured at scale in a safe, efficient and reproducible manner. Here's…
Polymorphism in Phamaceuticals
In pharmaceuticals, polymorphism refers to the occurrence of different crystal structures or forms of a solid drug substance. These forms are chemically identical but differ in their molecular arrangement or…
Pharma Industry- Patent Overview
Pharmaceutical patents are a form of intellectual property protection that grants exclusive rights to an inventor or their assignee to produce, use, sell or distribute a new drug or medicinal…
Pharmaceutical Guidelines
Pharmaceutical guidelines refer to a set of regulations, standards and recommendations that govern the development, production and distribution of medications to ensure their safety, efficacy and quality. These guidelines are…