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.
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) ?
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 lifecycle, i.e., development to post-marketing surveillance.
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 companies historically had little incentive to develop treatments.