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, review, and lifecycle management of regulatory information related to pharmaceuticals.
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 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 harmonization.
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.
