Pharmaceutical industries require their products to be able to promote drug safety during the lifecycle of such products. The Pharmacovigilance System Master File (PSMF) is one of the most important documents in favor of this endeavor in the European Union (EU) and other areas. So, what is a PSMF and why is this so essential to regulatory compliance?
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 (ASMF) is one of the most important means of helping to promote this integrity, as well as safeguarding proprietary information.
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 Masuu Global have been able to assist and guide the process of sponsoring the NDA submission process by offering clarity, compliance, and strategic precision to the sponsor.
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 a good foundation to launch your clinical development.
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 the specifications in and under which electronic records and electronic signatures are trusted trustworthy, dependable, and practically indistinguishable to paper records.