Category: Regulatory

Nitrosamine Impurity Risk Assessment: Ensuring Product Safety and Regulatory Compliance The use of nitrosamines in pharmaceutical manufacturing has become a major topic of interest because it is considered a probable carcinogen in humans. All regulators, such as the FDA and EMA, are currently mandating manufacturers to evaluate and mitigate the risk of nitrosamine impurities in… Continue reading Nitrosamine Impurity Risk Assessment: Ensuring Product Safety and Regulatory Compliance

What is an Investigational Medicinal Product Dossier (IMPD)? A Guide to the Investigational Medicinal Product Dossier Regulatory documentation is crucial in ensuring safety and effectiveness of the new medicines in the complicated world of drug development and clinical research. The IMPD, or the Investigational Medicinal Product Dossier is one of those key documents in the… Continue reading What is an Investigational Medicinal Product Dossier (IMPD)

What is an Active Substance Master File (ASMF) Submission and Why It Matters in Pharmaceutical Regulatory Strategy The pharmaceutical industry is a highly regulated sector where the quality, safety and efficacy of a drug product is highly reliant on the quality of its components-most predominantly the active pharmaceutical ingredient (API). The Active Substance Master File… Continue reading What is an Active Substance Master File (ASMF) Submission

New Drug Application (NDA) Submission: Your Path to U.S. Market Approval Marketing a product through pharmaceutical science is a major scientific and regulatory accomplishment. The NDA is the regulated pathway by which small-molecule drug developers can endeavor to obtain the authorization to market their products (via marketing approval by the United States FDA). We at… Continue reading What is New Drug Application (NDA) Submission

Investigational New Drug (IND) Application: Laying the Foundation for Clinical Trials Before a new drug can be tested in people in the USA, it must first get approval from the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) application. At Masuu Global, we guide sponsors through this essential regulatory gateway—giving you… Continue reading What is an Investigational New Drug (IND) Application

What is 21 CFR Part 11? In our digital era, FDA-regulated industries are supposed to be confident that their e-records and signatures are no less reliable than paper ones. It is here that 21 CFR Part 11 is used. It is an essential regulation developed by the U.S Food and Drug Administration (FDA) that establishes… Continue reading What is 21 CFR Part 11

What is a Clinical Trial Application (CTA) and Why it Matters Clinical trials play a vital role in the making of new medicines and treatments that lead to a healthier patient. But no new drug can be tested on human beings until the researchers in Canada get the official authority. This authorization is through a… Continue reading What is a Clinical Trial Application (CTA) and Why it Matters

What is a Biologics License Application (BLA) and Why is it Important in Drug Approval? Have you ever thought how innovative biologic medicines like vaccines, gene therapies, or monoclonal antibodies find their way into the lab, and into the hands of patients? One key component of this process is the Biologics License Application (BLA), a… Continue reading What is a Biologics License Application (BLA) and Why is it Important in Drug Approval?

What Is Drug Master File (DMF) Submission? Drug Master File (DMF) submission is a classified document that is submitted to the U.S. Food and Drug Administration (FDA) and entails detailed data regarding the manufacturing, processing, packaging or storage of the components employed in the pharmaceutical drug products.

Aggregate Reporting in Pharmacovigilance: A Critical Compliance Requirement A legal and ethical duty of pharmaceutical companies is safety monitoring of their products during the lifecycle; the drug development and post-marketing. As Individual Case Safety Reports (ICSRs) only involve recording individual adverse events, the focus is received on a bigger picture with aggregate reporting.