The final submission is the culmination of an entire drug program, yet it is often where strong assets stumble. Applications that are incomplete, inconsistent, or poorly structured can trigger extended review cycles, major information requests, or even a refuse-to-file decision. FDA reviewers are looking for a clear narrative of safety, efficacy, and quality that is easy to navigate and internally consistent. That requires linking data across clinical, nonclinical, and CMC modules while anticipating the questions reviewers will raise, and maintaining strict traceability so every table, figure, and claim can be verified.
HIC guides sponsors through every step of preparing NDAs, BLAs, 505(b)(2) applications, and ANDAs. Our regulatory leads and former FDA reviewers work directly with your team to confirm the optimal pathway, define the target labeling and the evidentiary positions supporting it, and design a submission architecture that matches how reviewers work through the Common Technical Document. We coordinate authoring and QC across functions, align summaries with underlying data, and shape strategies for first round questions and late cycle negotiations. The result is a marketing application that tells a clear story, minimizes surprises in review, and gives your product its best chance at approval.
Applications crafted for strong approvability arguments
- We draw on experts who have prepared and reviewed NDAs, BLAs, 505(b)(2), and ANDA submissions across multiple therapeutic areas
- Our team structures CTD modules so claims, tables, figures, and narratives are traceable from raw data through integrated summaries and proposed labeling
- We help craft labeling and benefit-risk positions that are both scientifically supported and competitively informed, strengthening your scientific and regulatory negotiation posture
- We anticipate reviewer questions, plan response strategies, and support your team through information requests so credibility and momentum are maintained throughout the review
