Lifecycle Support

Our regulatory operations team collaborates closely with clients to handle the formatting, publishing, and submission of regulatory documents. We meticulously project manage all regulatory communications with health authorities and ensure the maintenance of regulatory dossiers, including IDEs/INDs, CTAs, 510(k)s, PMAs/NDAs, BLAs, and more, along with any necessary amendments, supplements, safety reporting, and annual reports. We are committed to staying abreast of the latest technology to facilitate compliant submissions and foster accelerated development through technology-driven regulatory strategies.

At Halloran, we possess comprehensive expertise in all facets of regulatory affairs, including eCTD submissions. Our team is equipped to address your document preparation requirements, offering services such as document formatting, PDF publishing, eCTD creation, and submission via the FDA’s Electronic Submissions Gateway (ESG). Year after year, Halloran manages thousands of submissions across a spectrum of regulatory categories, from new drug applications to lifecycle submissions.

Already partnered with an eCTD publishing vendor but seeking additional document formatting support? Halloran's team is here to assist. We provide document preparation support to many clients, covering various document types, including nonclinical reports and clinical study reports. Our goal is to ensure that your regulatory documents are meticulously prepared, formatted, and submitted in accordance with regulatory standards, facilitating a seamless and efficient regulatory process.