Category: Regulatory

What is Clinical Regulatory Writing? Clinical Regulatory Writing is a highly specialized type of medical writing which facilitates the development, approval and post marketing surveillance of drugs and medical devices. It includes developing the necessary materials needed by international health regulators, including the FDA, EMA, and MHRA, when performing the clinical trial and regulatory submission… Continue reading What is Clinical Regulatory Writing

What is Aggregate Reporting? In the pharmaceutical industry, patient safety goes hand-in-hand with regulatory compliance. Aggregate Reporting is one of the most important instruments that allow this, a methodical way to analyze data on drug safety over time.

What is an Individual Case Safety Report (ICSR)? Drug safety after approval is an important issue in the pharmaceutical industry. Individual Case Safety Reports (ICSRs) are documents which report adverse events in patients and can be used to identify risks and comply with regulations. As a core element of pharmacovigilance, ICSRs support global health decisions.

What is Package Inserts (PIs) ? Package Inserts (PIs) are regulatory documents that are packaged with prescription medications, providing healthcare practitioners with crucial details of the safe and effective usage of the medications. PIs, approved by world health organizations, also include scientific information on indications, dosage, warnings, etc.

What Are Safety Labeling Changes (SLC)? In the world of pharmaceuticals, drug safety doesn’t end at approval. Once a medication is on the market, its real-world use often uncovers new safety information that wasn’t visible during clinical trials. This is where Safety Labeling Changes (SLC) apply.

In a digital-first healthcare ecosystem, clarity, consistency, and easy access to information about drugs are more important than before. That’s where the Structured Product Monograph (SPM) comes in a modern, structured, and machine-readable version of a traditional product monograph.

Drug information is important in highly regulated world of pharmaceuticals because use of incorrect information may result in an injurious outcome. The Structured Product Labeling (SPL) is one of the basic instruments that the U.S. Food and Drug Administration (FDA) employs in this undertaking.

What is Patient Information Leaflet (PIL)? Understanding your medication is as important as taking it correctly. One of the key tools that help patients make informed decisions about their health is the Patient Information Leaflet (PIL). Chances are, whether you are prescribed medication or purchase an over-the-counter product, it will have a PIL.

Accuracy and compliance are the key in the pharmaceutical profession and particularly when they present regulatory materials to health authorities. The simplest formatting mistake might mean rejection or subject to expensive delays. Submission eValidation guarantees that your electronic submissions are completed in all technical and structural compliance prior to sending regulators.

What is Submission Level Publishing? Regulatory submissions in the pharmaceutical industry are key processes that will dictate whether a drug or a medical product will make it to the market. In the setting of highly demanding regulatory requirements and complicated documentation, there has been the development of submission level publishing as a very important process… Continue reading What is Submission Level Publishing