IND Application Support

The investigational new drug (IND) application is a critical step in the drug development process. It is submitted to the appropriate regulatory agency such as Food and Drug Administration (FDA) to request permission to conduct clinical trials of a new drug in humans to evaluate the safety and efficacy of new drugs. The application must include detailed information about the drug's chemistry, manufacturing, and controls, as well as preclinical data demonstrating its safety and efficacy. The regulatory agency reviews the application to assess the risks and benefits of the proposed clinical trials and determine whether they can proceed. Without an approved IND Application, researchers are not permitted to conduct clinical trials in humans. Therefore, it is essential to ensure that the application is complete and accurate to avoid delays in the drug development process. However, preparing an IND application can be a complex and time-consuming task that requires meticulous attention to detail. Our company has in-depth knowledge of the registration regulations and policies of the United States, China, Japan, South Korea, India, the United Kingdom, Australia and the European Union and other countries and regions, as well as their technical requirements for chemical drugs, and thus can offer comprehensive IND Application support services to help streamline the process and ensure a successful submission.

Our IND Application Support Service

We offer comprehensive regulatory support to our customer to ensure compliant IND filing. Our team assists sponsors throughout the entire IND approval process, from pre-IND meetings to regulatory compliance and management of IND submissions, ensuring a smooth and efficient process until the IND becomes effective. The services include:

Consultation and Strategic Planning Advice in IND Filing

We help customers navigate the complex regulatory landscape by offering expert guidance on the necessary steps for successful IND filing.

Facilitation of Pre-IND Meeting

We facilitate pre-IND meetings between customers and regulatory authorities to discuss the proposed drug development plan, study design, and any potential concerns or issues.

Documentation Review

Our team conducts a thorough review of all necessary documentation, including administrative documents, animal pharmacology and toxicology studies, manufacturing information, clinical protocols, and investigator information to ensure compliance with regulatory requirements and guidelines.

Writing, Reviewing, and Preparation of IND Full Application Documents

We assist sponsors in the writing, reviewing, and preparation of IND/ANDA full application documents, ensuring all required documentation is accurately completed and in compliance with regulatory standards.

Strategic Response to Clinical Hold and Health Authority Questions

In the event of a clinical hold or questions from health authorities, our team provides strategic responses and support to address concerns promptly and effectively, ensuring minimal delays in the approval process.

IND Maintenance

We offer ongoing support for IND maintenance, including preparing and submitting amendments, annual reports, and safety reports as required by regulatory authorities to ensure compliance throughout the drug development process.

Registration Application Management and Tracking

Our team manages and tracks the entire registration application process, providing customers with regular updates on the progress of the application submission until successful completion.

Project Management Services

We provide comprehensive project management services to ensure efficient coordination of all activities related to the IND application process, from initial submission to approval and beyond.

Our Advantages

There are several advantages to using our IND application support services.

It should be noted that our service is only used for research, not for clinical use.