Before a new drug can be tested in people in the USA, it must first get approval from the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) application. At Masuu Global, we guide sponsors through this essential regulatory gateway—giving you a good foundation to launch your clinical development.
What Is an IND Application?
An IND is an official request to the FDA to start clinical trials using a new drug or biological on human subjects. It is an important stage at the end of preclinical development and its purpose is to offer the FDA all the information it needs to determine the scientific validity and safety of the proposed clinical tests on a human.
Clinical trials of unapproved products using an experimental drug may not go on in the U.S. without an active IND.
When is IND required?
- A sponsor must have an IND when they plan to:
- A new chemical or biological entity to be tested in humans.
- Use an existing drug to treat a novel indication in dosage or population.
- Carry out clinical research in the U.S. using a drug that must be marketed in the future.
The major Elements of an IND filing
An entire IND submission requires data that is sufficient to guarantee the safety of the participants involved in the trials as well as the scientific integrity of the intended protocol. The application normally consists of:
- Preclinical Data: Pharmacology and toxicology animal studies results, to show safety profile of the drug.
- Chemistry, Manufacturing, and Controls (CMC): Comprehensive data on the chemical substance, formulation, process of manufacturing the drug and controls to assure drug quality.
- Clinical Protocols: Stipulated study design, purpose, method, dose, type of inclusion/exclusion criteria and safety monitoring.
- Investigator Information: Who should be qualified as clinical investigators and site information.
- Investigator Brochure (IB): Overview of clinical and nonclinical data in support of drug administered safely in humans.
INDs should be registered in a format prescribed by FDA and should be sent in electronic format using eCTD, with exception.
Masuu Global IND Submission Support
Our regulatory support is done in the end-to-end IND planning, IND preparation, and the IND filing. We offer services in the field of:- Gap analyses and planning strategic regulation.
- Compilation and writing of IND modules and study protocol.
- Clinical Trial Guidance on IND meetings with the FDA.
- CMC readiness evaluation and manufacturing documentations aids.
- Nonclinical data analysis and combination.
- Validation Electronic submission of eCTD.
- Regular maintenance and amendment of the IND and reporting on the safety.
Our dedicated team members collaborate extensively with your scientific and operational personnel so that your IND submission is correct, comprehensive, and congruent with FDA anticipations.
Why Masuu Global?
The submission of IND is an important step in the journey of drug development. The approval can be delayed due to errors or omissions and have ramifications to trial schedules. Masuu Global provides the combination of a broad understanding of regulation and technical expertise mixed with practical experience to assist you and fast-track clinical entry.
We support your first or fifth IND and all your investigational programs with the skills and services you require to proceed with clarity in clinical development.