Regulatory Operations

At Halloran, we excel in all facets of regulatory affairs, however one or our particular sweet spots is specializing in eCTD submissions. Our dedicated team offers comprehensive support for your document preparation needs, covering everything from document formatting to PDF publishing, eCTD creation, and submission via the FDA’s Electronic Submissions Gateway (ESG). For more than two decades, we've handled thousands of submissions, ranging from new drug applications to lifecycle submissions.

Already working with an eCTD publishing vendor but require additional document formatting support? Halloran’s expert team provides document preparation assistance to many of our clients, including nonclinical reports and clinical study reports.