Author: masuuglobal
What is Clinical Regulatory Writing
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 Qualified Person (QP)
What is Qualified Person (QP)? The Qualified Person (QP) is very important in pharmaceutical manufacturing as it ensures that medicinal products adhere to all required quality and regulatory specifications before being released in the market. Pharmaceutical regulations in most countries and especially in the European Union require this role and it is essential to the… Continue reading What is Qualified Person (QP)
What is a Drug Regulatory Authority
What is a Drug Regulatory Authority? In the pharmaceutical sector, integrity of drug development, production, and distribution matters most. The main role of Drug Regulatory Authority (DRA) is to ensure that the pharmaceutical product is of the set standard of safety, quality and efficacy.
What is Claim Substantiation
What is Claim Substantiation? Claim substantiation in pharmaceutical business is a very important process whereby all claims that are related to products such as therapeutic, preventive and supportive ones are supported by reliable scientific facts. The practice is not only a regulatory liability but also a pillar of an ethical marketing practice and patient safety.
What is Clinical Regulatory Writing
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 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.