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.
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 Clinical Trial Application (CTA) by Health Canada.
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 formal submission to the U.S. Food and Drug Administration (FDA) that guarantees the adherence to rigorously high safety, effectiveness and quality standards of these complex medicines before they are approved to market.
