A recent client approached us for assistance in submitting an updated IND application to the FDA. They had switched from using 3 x 2ml ampoules to a 6ml pre-filled syringe for their co-packaged product. While their product development partner excelled in technical studies and development reports, they needed our expertise to ensure regulatory compliance.
The twist came when they asked their development partner for a detailed proposal outlining the necessary dossier sections in line with their regulatory strategy agreed upon with the FDA. Despite the proposal being thorough in the Pharmaceutical Development section, it astonishingly overlooked 12 out of the 13 required dossier sections.
This oversight, which we promptly identified, highlighted a critical gap. The development partner’s strength in product development did not extend to regulatory affairs. Imagine submitting an IND application where only one out of thirteen agreed sections is addressed—this would undoubtedly raise significant concerns with the FDA and jeopardise the approval process.
Even if they amend their proposal to include these 12 sections for dossier submission, how confident you think our client would be that they will draft and finalise the sections according to regulatory requirements? This is crucial not only to preempt a barrage of follow-up questions from the FDA but also to avoid potential complications that could arise from presenting the dossier sections inadequately, leading to a cycle of endless queries and responses, delaying the product’s approval process and potentially harming the credibility as an applicant.