Brazil is a huge pharmaceutical market that offers the pharmaceutical manufacturer fantastic potential. Registration of pharmaceuticals is a long procedure in Brazil involving various steps. In fact, it is an intricate procedure.  It is not simple for pharmaceutical manufacturers to gain access to the Brazilian Regulatory Authority's marketing of medications and biologics. The Portuguese Agencia…

Drug development and drug approval process in Europe is subject to stringent laws and guidelines to ensure that the drugs are safe, effective, and of high quality. Pharmaceuticals are evaluated and monitored in the European Union (EU) by the European Medicines Agency (EMA). To manufacture medications in Europe, a manufacturer must first get a manufacturing…

Reference Listed Drugs (RLDs) are approved innovator medicines. These branded medicines are the first to be introduced on the world market and serve as reference products. Reference products are the benchmark for generic drugs when it comes to quality, safety, and efficacy. The procurement and supply of RLDs typically involve the research-based innovator pharmaceutical companies…

The comparator sourcing market deals with exploring the availability and source of the comparator drug followed by its acquisition and supply.  The reference or comparator drugs are required in conducting clinical trial studies that compare the efficacy and safety of the test formulation or an investigational new product to those of an existing approved…

Cell and gene therapy belong to the field of biomedical research and is currently categorized as an experimental treatment.  Both these therapies are targeted to treat, prevent, or potentially cure diseases that have no other treatment available. Their use is aimed to alleviate the underlying cause of genetic diseases and acquired diseases. Both cell and gene…

Clinical trials are the backbone of the drug development program and impact the success of bringing new products to the market. Therefore, clinical trial conduct requires efficient supply-chain logistic support to manage study timelines. Risk-based optimization helps achieve efficiency, cost, and time effectiveness in this important activity. Every clinical trial requires varied supplies specific to…

Biological sample management refers to the methodical and organized processing, preservation, and disposal of products obtained from biological source and classified as biological products. It also includes biological specimens such as tissue, blood, and body fluids. Biological products deteriorate at ambient and high temperatures and lose their potency and intended pharmacological activities. In order to…

IPR is an abbreviation for Intellectual Property Rights that is legally bestowed upon innovators to protect their intellectual innovations. IPRs are classified into three types: patents, copyrights, and trademarks. Patents- Patents are a collection of exclusive rights awarded to an inventor or licensee for a limited time in exchange for the general disclosure of the…

A Reference Listed Drug (RLD) is the original, innovative, branded product that has been approved by regulatory agencies such as the Food and Drug Administration (FDA) in the United States and the European Medicinal Agency (EMA) in the European Union. The RLD continues to remain as a standard or benchmark for the generic copies to…