Regulatory IND Readiness Assessment & Roadmaps

Regulatory readiness assessments, also known as gap assessments, are indispensable exercises performed throughout a product's life cycle. Our team conducts a thorough assessment of potential regulatory risks that could affect your business and the ongoing development of your product. It's prudent for sponsors to conduct these assessments before engaging with the U.S. Food and Drug Administration (FDA) on milestone interactions or substantial submissions to mitigate any Information Requests (IRs) or deficiencies the FDA may identify during their review.

At Halloran, we routinely conduct readiness assessments for our clients. These assessments occur before the original investigational new drug (IND) submission, New Drug Application (NDA) / Biologics License Application (BLA) submission, or at any point in between. Leveraging our regulatory expertise across various product modalities and therapeutic indications, as well as insights gained from frequent interactions with the FDA, we tailor our approach based on our clients' needs, timelines, and development status. Our aims include:

• Harnessing regulatory intelligence gathered from our numerous FDA engagements to inform clients about FDA hot topics and current areas of focus
• Providing an integrated assessment of risks relevant to the current and upcoming development milestones or regulatory submissions, along with recommendations and mitigations
• Developing a risk register and rating identified risks based on their impact on timelines and costs
• Offering recommended next steps for continued development