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
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What is Electronic Common Technical Document (eCTD)
What is Electronic Common Technical Document (eCTD)? Regulatory submissions are an important aspect of drug development and approval in the pharmaceutical industry. Electronic Common Technical Document (eCTD) has been developed to standardize and simplify the process of providing information to regulatory bodies. The eCTD is an internationally recognized format designed specifically to improve the submission,… Continue reading What is Electronic Common Technical Document (eCTD)
What is Aggregate Reporting
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)
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 eCTD 4.0?
What is eCTD 4.0? The level of regulatory efficiency is essential in the modern rapidly changing pharmaceutical environment. The most recent global standard aimed at simplifying drug submissions is Electronic Common Technical Document (eCTD) 4.0. It streamlines regulatory authority and pharmaceutical firm communication, management and tracking of submission content- providing greater efficiency, accuracy and global… Continue reading What is eCTD 4.0?
GMP Audit Best Practices: Ensuring Compliance and Quality with Masuu Global
GMP Audit Best Practices: Ensuring Compliance and Quality with Masuu Global Why GMP Audits Matter: Good Manufacturing Practice (GMP) audits are essential in regulated industries such as pharmaceuticals, biotechnology, food, and cosmetics. They help ensure product quality, safeguard consumer safety, and meet requirements set by agencies like the FDA, EMA, and other regulatory bodies.
What is Non-Clinical Regulatory Writing
What is Non-Clinical Regulatory Writing? In the pharmaceutical industry, precision, compliance, and scientific clarity are critical at every stage of drug development. Among the most vital, though least used roles in this process, is non-clinical regulatory writing, a medical writing type in which accurate non-clinical information is conveyed to world regulatory authorities.
What is a Risk Management Plan (RMP)
What is a Risk Management Plan (RMP) ? A Risk Management Plan (RMP) is a detailed report that the pharmaceutical industry needs to make sure the benefits of a pharmaceutical product exceed its dangers. It is a required component of regulatory submission, especially in the European Union, and is a key element of the product… Continue reading What is a Risk Management Plan (RMP)
What is Orphan Drug Designation (ODD)
What is Orphan Drug Designation (ODD)? Orphan Drug Designation (ODD) is a regulatory designation that applies to those types of medicine which have been specifically designed to treat a rare disease commonly referred to as an orphan disease. These diseases affect a small fraction of the population, and because of the limited market potential, pharmaceutical… Continue reading What is Orphan Drug Designation (ODD)
What is Pharmacovigilance System Setup
What is Pharmacovigilance System Setup? Pharmacovigilance (PV) is an important part of the pharmaceutical sector as it plays a crucial role in ensuring safety of medicinal products in their lifecycle. Marketing Authorization Holder (MAH) and clinical research organizations (CROs) are obliged to establish a compliant pharmacovigilance system in accordance with the requirements of global regulations.