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.
RELATED INSIGHTS
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Raw Material Control for Biotechs (Part 2): Clinical Development Considerations
Introduction This is part two of the Halloran Insights article on raw material control. Raw Material Control for Biotechs Part one addressed the importance of establishing a level of raw material control at the earliest stages of product development. This article will focus on maturing the raw material control strategy in preparation for a commercial […]
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Moving from Discovery to Commercialization in Precision Medicine
The revolution in precision medicine, a form of medicine using information about a person’s own genes or proteins to prevent, diagnose, or treat disease, has reached an exciting phase with the advancement of cell and gene therapies (CGTs). Precision medicine, also known as personalized medicine, is an approach to patient care that enables treatments most […]
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Rare But Not Forgotten: Opportunities in Rare Disease Drug Development
This article was co-written by Samantha Zappia, Principal Consultant, SK Regulatory Solutions. The World Orphan Drug Congress (WODC) brings together industry leaders working to advance orphan and rare disease drug development in one place for a unique three-day event. Many attendees arrive with the goal of meeting other players in the industry, learning from successes […]
