IND Application, IND Submission, Pre IND Meetings, IND Filing

Freyr provides Regulatory Affairs service support to the Innovator medicine companies during IND filing process, starting from pre-IND meetings to IND submission and further to regulatory compliance & maintenance.
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

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