U.S. Investigational New Drug (IND) Application

Background of IND Application

The investigational new drug (IND) application is a crucial step in drug development in the United States. Before an innovative drug can be tested on humans, it must first undergo extensive preclinical testing to ensure its safety and efficacy. Once this testing has been completed, an IND application can be submitted to the US Food and Drug Administration (FDA), which allows the drug to be tested in clinical trials. The IND application must contain information in three broad areas, including animal pharmacology and toxicology studies, manufacturing information, clinical protocols, and investigator information.

At the IND filing stage, the FDA generally requires that a drug applicant must:

• Complete pharmacological studies of the drug;
• Conduct acute toxicity tests on at least 2 kinds of animals;
• Conduct short-term studies for a period of 2 weeks to 3 months in accordance with the proposed use of the drug.

About Us

Our regulatory experts provide reliable IND application services to help our clients navigate the complex FDA regulatory landscape.

Our team of experts can assist our clients with preclinical testing to meet FDA requirements, including in vitro and in vivo studies to assess the pharmacokinetics, toxicology, and efficacy of the drug. Our clinical registration service platform has an in-depth understanding of regulatory policies and technical requirements for chemical drugs in the United States and can provide domestic and international clients with consultation on drug development and registration strategies, as well as preparation and submission of IND applications. Our one-stop clinical research, full project management, and registration services provide our clients with the expertise and support they need to successfully complete the drug development process in the United States. With our customized solutions and experienced team, we are well-positioned to help our clients bring investigational drugs to market.

Our IND Application Services

We offer a comprehensive suite of services to support our clients in preparing and submitting IND applications. After the application materials are submitted, our senior filing person in charge will keep in communication with the regulator and follow up on the application progress in real time until the application is successfully completed. Our services include:

• Regulatory consulting
• Provide consultation on drug registration regulation
• Provide project evaluation and risk analysis
• Design registration application strategy
• Estimate project costs, plan project timelines, and ensure compliance
• Research service (pharmacology (API, formulation), pharmacodynamics, toxicology)
• IND application
• Pre-IND meeting preparation
• CTD document review, translation, and preparation
• IND document preparation and submission
• Communication with regulatory agencies
• Site inspection preparation
• Management and tracking of the entire application process
• Project management
• Guide project direction, progress, quality, and budget
• Supervise study proposals to meet overall scope requirements
• Organize phase reviews and prepare reports
• Manage samples and documents to meet regulatory requirements
• Manage outsourced collaborations

Our Advantages

• Familiar with FDA review philosophy and regulatory requirements, with rich resources of FDA review experts
• Provide clients with targeted technical, regulatory, and filing strategy recommendations to meet registration requirements
• Extensive IND application and project management experience
• Industry-leading comprehensive preclinical development expertise

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