For conducting clinical trials with investigational drugs or drugs that are not approved for intended use, the sponsor must submit an Investigational New Drug Application (INDA) to the US FDA and obtain the Agency’s acceptance. Post the INDA approval, the drug is transported or distributed across the US for use in the clinical programs. If the sponsor fails to submit adequate information in the INDA to assure product quality, safety, and scientific evidence on proposed efficacy profile, the US FDA may issue a Clinical Hold (full clinical hold or partial clinical hold), restricting sponsors to move forward unless issues are addressed.
Freyr assists sponsors with 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.
- Gap-analysis of IND developmental data against the current federal Regulatory requirements for conducting human clinical trials, and identify potential clinical hold issues (Critical & Major).
- Regulatory support for pre-IND meetings and other agency communications (Type A, Type B, Type C, and Biosimilar Biological Product Development (BPD) meetings).
- Request for ODD (Orphan Drug Designation) or for expedited review program designations.
- Strategic support in identifying the optimal Regulatory approach for an intended clinical program(s) and IND submission.
- Expert advice on Regulatory mitigation plans for identified data deficiencies and clinical hold issues during the IND process.
- Extensive understanding on NDA/BLA submission requirements and data correlations from IND to future Marketing Authorization Applications.
- Publishing and eCTD submission of initial INDs and subsequent submissions (IND annual reports, amendments, etc.).
- Regulatory response strategy, preparation, and on-time response submission to the US FDA queries/information requests.
- Consulting support for IND inactivation or IND re-activation.
- US agent services.
- Preparation, technical review, and submission of CMC, nonclinical & clinical packages for initial IND submission, IND amendments, safety reporting, and IND annual reports submission in the eCTD format for different types of medicinal products (new chemical entities, vaccines, biosimilars, and other biological products like tissue and gene therapy products, etc.)
- IND submission templates in eCTD format.