U.S. New Drug Application (NDA)


Background of IND Application

U.S. New Drug Application (NDA)

According to laws and regulations such as The Food, Drug and Cosmetic Act and Code of Federal Regulations Title 21, the new drug review process of the US Food and Drug Administration (FDA) includes two parts: IND application for new drug clinical trials and NDA application for new drug marketing. After the clinical trial is over, the sponsor can submit an NDA to the FDA when they have sufficient reasons to prove that the safety and effectiveness of the drug meet the FDA's requirements for marketing. An NDA is a comprehensive document that provides detailed information about a drug, including its safety and efficacy, manufacturing process, and proposed labeling. All new drugs must go through the new drug review process in order to be marketed in the United States. Upon approval, the appropriate sponsor or affiliate will be given the legal right to sell and market their drug therapy.

About Us

Our company offers a range of NDA services to help our clients navigate the FDA approval process.

The NDA submission process is a critical step in the approval of new drugs for use in the United States. At our company, we specialize in providing NDA submission services to pharmaceutical companies, with a focus on expertise, attention to detail, timeliness, and communication. Our professional NDA research team has rich experience in project management and is able to prepare the best application plan for our clients according to the characteristics of the drugs under development, thus effectively shortening the new drug development cycle and facilitating the launch of new drugs. Our efficient and comprehensive project management process and expertise in US drug regulations ensure that filings are prepared and submitted to a high standard.

New Drug Application

We help clients with NDA applications for new drugs that meet any of the following criteria:

  • New molecular entity (NME)
  • New chemical entity (NCE)
  • New salt group and new ester group of the same chemical composition as the originally approved drug
  • The new formulation composition of the originally approved drug
  • New indications of originally approved drugs (including prescription drugs to non-prescription drug use)
  • New dosage forms, new routes of administration, new specifications (unit content)
  • New combinations of more than two previously approved drugs

Our NDA Regulatory Services

Our outstanding regulatory experts offer a variety of benefits to all parties, including sponsors who need to submit and navigate the final leg of the drug development process, to increase the likelihood that the NDA will be approved. With expertise in the NDA, our team of industry experts can assist in:

  • Analyze the feasibility of NDA registration of the drug in the U.S. based on U.S. regulatory requirements
  • Gap analysis of registration dossiers and pre-review of drug information
  • Pre-NDA/BLA meeting assistance
  • eCTD publishing and electronic submission
  • Follow-up of the official review process of drug registration
  • Submission of answers to FDA's supplementary questions and supplementary materials
  • Pre-review of cGMP compliance
  • Project planning and management
  • FDA communication
  • Post-approval support

Our Advantages

  • Professional application materials writing team with excellent multilingual communication skills
  • Decades of experience in researching U.S. drug regulations to ensure professional technical consulting services
  • Long-term friendly communication with officials and industry experts to significantly improve service quality and efficiency

If you need help or have a question, please feel free to contact us for more details.

Contact Us

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