New Drug Application (NDA)

Navigating the complexities of drug development and regulatory approval is a daunting task. Our New Drug Application (NDA) services are designed to guide you through this critical phase, ensuring that your submission is thorough, compliant, and stands the best chance of approval.

What is NDA?

A NDA is a formal request to the U.S. Food and Drug Administration (FDA) to approve a new pharmaceutical drug for sale and marketing in the United States. NDA is a critical step in the drug development process, allowing pharmaceutical companies to bring new innovative medicines to patients. The rigorous FDA review helps ensure the safety and efficacy of new drugs.

Some key points about NDA:

• NDA contains all the information about the safety and effectiveness of a new drug, including results from clinical trials.
• The NDA submission must include information on the drug's composition, manufacturing, packaging, labeling, and quality control. It also requires data from studies on the drug's pharmacology, toxicology, and clinical trials.
• The FDA review process for an NDA can take 6-10 months on average.

Our comprehensive NDA support

Protheragen-ING Lab's NDA research team has extensive project management experience and is able to develop optimal filing programs for clients based on the characteristics of the drugs in development, thus effectively shortening the development cycle and facilitating the launch of new drugs. Our efficient and comprehensive project management process and expertise in U.S. drug regulations ensure that filings and submissions meet high standards.

NDA

We help clients submit NDA 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.

NDA Regulatory Services

Our regulatory experts provide a variety of benefits to parties, including sponsors, who need to submit and complete the final stages of the drug development process to increase the likelihood of NDA approval. With expertise in NDAs, our team of industry experts can assist:

• 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.

Why choose Protheragen-ING Lab for your NDA submission?

• Deep regulatory expertise spanning all stages of the NDA process.
• Proven track record of successful NDA submissions and approvals.
• A tailored approach to meet the unique needs of your drug program.
• Responsive, personalized service from an experienced team.
• Competitive pricing and transparent fee structures.

Take the next step in your drug development journey with confidence. Contact us today to learn more about our NDA services and how we can support your path to regulatory approval.