Regulatory Operations Support

Halloran excels in Regulatory affairs, encompassing eCTD submissions. Our adept team is fully equipped to address your document preparation requirements, covering document formatting, PDF publication, eCTD compilation, and submission through the FDA's Electronic Submissions Gateway (ESG). Annually, Halloran handles thousands of submissions, spanning from new drug applications to ongoing lifecycle submissions.

If you already have an eCTD publishing vendor but require document formatting assistance, our dedicated team at Halloran offers document preparation support for numerous clients, extending to nonclinical reports and clinical study reports.