Investigational New Drug (IND) Applications are very crucial when conducting clinical trials with investigational drugs or drugs that are not approved for intended use, the sponsor must submit an IND Application to the US FDA and obtain Agency acceptance before the drug is transported or distributed across the US for use in the clinical program.
Importance of Adequate Information in IND Application
Inadequate information in the IND Application, including product quality, safety, and scientific evidence on proposed efficacy profile, can lead to a Clinical Hold issued by the US FDA. A Clinical Hold can restrict sponsors from moving forward until the issues are addressed.
Challenges in the IND Filing Process
Several challenges may arise during the IND filing process. Including identification of regulatory requirements, GMP/GLP compliance, product-specific scientific knowledge, managing clinical hold issues. Parallel planning of IND filing process, and managing ongoing CMC changes/protocol changes.
Identification of Regulatory Requirements for the IND Application
One of the most significant challenges in the IND filing process is identifying the regulatory requirements for the intended IND Application. This involves understanding the different phases of clinical trials and the associated regulatory requirements.
Managing Clinical Hold Issues
Sponsors must develop appropriate mitigation plans for potential clinical hold issues. This involves a comprehensive understanding of the clinical hold process and working closely with the FDA to address any concerns.
Templarpharma’s End-to-End Regulatory Support for IND Programs
Templarpharma provides end-to-end regulatory support for IND programs, starting from pre-IND meetings to regulatory compliance and management of late phase submissions when the IND goes effective. This includes managing ongoing CMC changes/protocol changes, safety reporting, annual reporting, and ensuring compliance with regulatory requirements.
Importance of Parallel Planning and Product-Specific Scientific Knowledge
Parallel planning of the IND filing process and other clinical trial-related logistics, such as clinical trial sites’ readiness, clinical material manufacturing & testing, and cGMP compliance at CMO sites, is critical to ensure a successful IND filing process. Additionally, product-specific scientific knowledge is essential to manage regulatory issues related to new chemical entities, biologics, radioactive labeled drugs, etc.
In conclusion, the IND filing process is a critical step in conducting clinical trials with investigational drugs or drugs not approved for intended use. The process involves several challenges, including identifying regulatory requirements, managing clinical hold issues, and ensuring product-specific scientific knowledge. Templarpharma provides end-to-end regulatory support to sponsors to ensure compliant IND filing and manage ongoing regulatory compliance throughout the clinical trial process.
Expertise in Investigational New Drug (IND) Applications
Generally offer a range of regulatory services to support clinical programs and IND submissions. Expertise includes identifying the optimal regulatory approach, providing regulatory support for pre-IND meetings and other agency communications. And assisting with requests for orphan drug designation and expedited review program designations.
Conduct a gap analysis of IND developmental data against current federal regulatory requirements to identify potential clinical hold issues and provide expert advice on regulatory mitigation plans for any identified data deficiencies or clinical hold issues.
Team has an extensive understanding of NDA/BLA submission requirements and data correlations from IND. To facilitate future Marketing Authorization Applications. prepare, technically review, and submit CMC, non-clinical. And clinical packages for initial IND submissions, IND amendments, safety reporting. And IND annual reports submission in the eCTD format for various medicinal products such as new chemical entities. Including vaccines, biosimilars, and other biological products including tissue and gene therapy products.
Also provide IND submission templates in the eCTD format. As well as publishing and eCTD submission of initial INDs and subsequent submissions (IND annual reports, amendments, etc.). Regulatory response strategy ensures timely submission of responses to US FDA queries and information requests. Consulting support includes assistance with IND inactivation or re-activation, as well as US agent services.