Skip to Content

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

  • This article is based on opinions and perceptions from the DIA 2024 Global Annual Meeting, in San Diego, June 2024. Many thanks to our contributors: April Purcell (Specialist) and Michelle Peter (Senior Specialist). The team sat down with Gail Winslow, Head of Marketing, after the conference to share their experiences.   From start to finish, several […]

  • This article is based on the session titled, “Shifting Medical Writing Value Propositions with the Use of Technology,” at the DIA 2024 Global Annual Meeting, in San Diego, June 2024. Many thanks to the presenters: Robin Whitsell (Whitsell Innovations), Joanne Hilton (GlaxoSmithKline), and Kayla Williams (Takeda) for their valuable insights. This translation is the author’s […]

  • This article is based on the session titled, “Sustainability of Rare Disease Drug Development,” at the DIA 2024 Global Annual Meeting, in San Diego, June 2024. Many thanks to the presenters: Darcy Frear (Bridgebio), Katherine Donigan (Sarepta), Karin Hoelzer (NORD), Patroula Smpokou (FDA), and Julia Tierney (FDA) for their valuable insights. This translation and the […]