Successfully Navigating The IND Process
The Investigational New Drug (IND) application is a critical piece in getting a new therapy greenlighted for human clinical trials. To best inform the content of the IND, your clinical trial design, and have the agency address as many of your questions/concerns as possible prior to submission, sponsors are urged to request a Type B Pre-IND meeting with FDA. Submitting an application that meets and exceeds FDA requirements on the first attempt is essential to maintaining your drug development timeline.
Properly completing the IND application requires an in-depth understanding of all regulatory affairs and guidelines. Due to the large amount of data and supplemental information required for this application, it is not uncommon for missteps to occur on the sponsor’s side. Errors can take place in the IND preparation, authoring, and publishing phase which could delay drug advancement or potentially put a program on clinical hold.
Download our IND whitepaper on how to successfully navigate through the application process.
Who is BioPharma Global?
BioPharma Global is a full-service regulatory affairs consulting firm specializing in orphan products to treat rare diseases and non-orphan products to treat indications with unmet medical needs. We offer services such as orphan drug designations and other expedited review programs, provide support for meetings with the FDA and EMA, IND filings, and comprehensive consulting on projects for regulatory strategy.
Our team of experienced consultants has helped numerous drug sponsors successfully navigate the IND application and get their therapy approved for clinical trials. Our staff has submitted countless applications for a variety of indications, and has a 100% success rate when clients follow our instructions.