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Regulatory Lifecycle Support

How we help with Regulatory Lifecycle Support

Our regulatory operations team partners with our clients to format, publish, and submit regulatory documents on their behalf. We will attentively project manage all regulatory communications with health authorities and maintain all regulatory dossiers (IDEs/INDs, CTAs, 510(k)s, PMAs/NDAs, BLAs, etc.) with amendments, supplements, safety reporting, and annual reports.  We stay ahead of the latest technology to support compliant submissions and promote accelerating development through technology-enabled regulatory strategies.

Halloran has expertise in all aspects of Regulatory, including eCTD submissions. Our team can fully service your document preparation needs for document formatting, PDF publishing, eCTD creation, and submission through the FDA’s Electronic Submissions Gateway (ESG). Year after year Halloran processes thousands of submissions ranging from new drug applications to lifecycle submissions. Already have an eCTD publishing vendor but looking for document formatting support? Halloran’s team provides document preparation support for many of our clients including nonclinical reports and clinical study reports.