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.
What Is a New Drug Application (NDA)?
An NDA is the official regulatory filing to the FDA asking to license a new drug in the US. It gives detailed data on safety, efficacy, and pharmacokinetics of the drug, the quality of its manufacture, and recommended labeling. The FDA applies it to establish that the benefits of a particular drug outweigh its risks and can be safely used in clinical practice.
The submission of NDA usually comes during the end of the multiple years of research, development, preclinical investigation, and Phase 1-3 trials.
The Salient Features of an NDA Filing
A solid NDA should have comprehensive and scientifically supportive data in many fields. Core contents are:- Administrative and Regulatory paperwork: Forms, cover and user fee payment document.
- Preclinical (Nonclinical) Data: Animal toxicity, Pharmacology/safety, and animal studies.
- Clinical Study Reports: Evidence on the effectiveness and safety in target populations of the drug based on the outcome of human trials.
- Chemistry, Manufacturing, and Controls (CMC): Information on the composition, the manufacturing process, including formulation, and quality controls of the drug and stability.
- Labeling: Patient Information, package insert, and drug guides.
- Risk Management Plan: Pharmacovigilance plans and strategies of post-marketing safety surveillance.
The NDA has to be prepared in the Common Technical Document (CTD) arrangement and submitted electronically in the eCTD (Electronic Common Technical Document) program.
The NDA Submission Services of Masuu Global
We specialize in offering the full range of services to pharmaceutical sponsors who are getting ready to submit an NDA at Masuu Global. Our services will help minimize regulatory risk, make the process easier by streamlining it, and help align the submission plans with FDA expectations.
Our professional regulatory affairs staff assist the clients in:- Submission of plans and regulatory pathways,etc.
- Revise, edit and compose the CTD Modules 1-5.
- Take care of data integrity and regulations.
- Drive and guide the FDA interactions, such as Pre-NDA, and End-of-Phase meetings.
- Be ready to experience regulatory examinations and demand information.
- Put eCTD publishing, validation on schedule and submit.
We are an assisting arm of your internal team with the right technical knowledge as well as regulatory expertise to speed up approval.
Why Masuu Global?
The process of filing an NDA is complicated and risky and should be executed exactly due to the extensive knowledge of the regulations. Masuu Global concentrates cross-functional experience in regulatory, clinical, and CMC fields to help coordinate NDA submissions without any hitches.
Masuu Global provides personalized services to any startup looking to get their first round of NDA done, or an established business looking to streamline regulatory pathways.
