Halloran Consulting Group is a life science consulting firm offering services across five expertise areas, enabling the end-to-end development lifecycle, from discovery, through clinical & regulatory, to commercialization and product launch. Our deep bench of strategic advisors and hands-on consultants stand ready to serve your organization as a true partner in the quest of improving human health. Our expertise areas include: clinical development & operations, regulatory affairs & operations, quality & compliance, organizational excellence, data & technology, project leadership & program management. Let us guide you in future proofing your organization.

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Halloran’s Feedback On FDA’s Electronic Systems, Records, And Signatures Guidance

The Clinical Operations Retreat for Executives (CORE West) recently brought together leaders in the life sciences sector to explore the modernization of clinical trials. Review attendees' feedback from an interactive workshop where the U.S. Food and Drug Administration's latest draft guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations” was discussed.



Halloran Consulting

22 Thompson Place

Boston, MA 02210


Phone: 617.648.7879

Contact: Tania Zieja, President


3040 Science Park Road, Suite 1300
San Diego, CA 92121


  • Learn how Halloran's assistance was able to improve a rare disease biotechnology company’s development and operations, communication workflow, and avoid the delay of a gene therapy trial.

  • Uncover how a multiphased approach helped a small biotech to organize its programs so that it could efficiently make decisions, timely adapt to changes in strategy, and better understand current activities.

  • By reviewing this established network of repeat customers and best-in-class partners, unearth how companies have been able to maintain effective interactions with regulatory agencies.

  • Learn how we can customize our approach for every engagement, helping clients from the pharmaceutical, medical device, and biotech spaces reach pivotal milestones with success.

  • With the right partner, learn how you can begin addressing document preparation requirements, document formatting, PDF publication, eCTD compilation, and submission needs through the FDA's Electronic Submissions Gateway (ESG).

  • Get unique insights into current expectations set by the U.S. Food and Drug Administration and the European Union, as well as distinctions between Orphan Drug Designation (ODD) criteria for the two entities.

  • Having led or supported approximately 22 formal meetings with the FDA annually, discover how Halloran has helped companies craft regulatory strategies, prepare documentation, and orchestrate FDA discussions.

  • Learn how your company can enable productive interactions with inspectors through Inspection Readiness (IR) gap assessments, and propel to the next phase of development.