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Insights From Halloran

Josh WootenMay 8, 2025 7:57:17 AM1 min read

Start it off Right: The Importance of Building an IND from High-Quality Nonclinical Reports

Nonclinical reports are one of the most critical pieces for building an IND, but are ...
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Meghan Patterson, MPHMay 2, 2025 11:23:42 AM3 min read

Balancing Simplicity and Complexity in Clinical Trial Design

Designing clinical trials is a nuanced process that often pits the ideal of simplicity ...
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Steve Kornher, PhDApr 28, 2025 3:12:28 PM8 min read

Risk Mitigation Planning for Pharmaceutical Tariffs

The impact of tariffs on the pharmaceutical and biotechnology industries is unclear as ...
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Meghan Patterson, MPHApr 22, 2025 12:32:06 PM4 min read

ICH E6(R3) and a Risk-Based Approach as a Competitive Advantage 

By Meghan Patterson
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Elizabeth BodiApr 14, 2025 5:52:43 PM1 min read

Key Update on Guideline for Good Clinical Practice E6(R3)

January 6, 2025: ICH assembly agreed that ICH GCP E6 R3 Principles and Annex 1 could be ...
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Mike Fusakio PhDApr 14, 2025 4:38:00 PM2 min read

Impact on Product Development: FDA Phasing Out Animal Testing Requirement

Contributing Author: Hema Balasubramanian The FDA announcement on its plan to phase out ...
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Carolina Ahrendt, MBA, PMPApr 10, 2025 12:40:26 PM6 min read

Ticking Timeline: Tips for Effective Product Development Timelines

Once a biotech or pharmaceutical company defines their product development objectives ...
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Sheila GwizdakApr 7, 2025 9:34:32 AM1 min read

Impacts of ICH GCP E6 (R3) Webinar

Join Halloran Consulting Group for a compelling discussion on how to future-proof your ...
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Kanchana IyerApr 3, 2025 10:30:00 AM3 min read

Navigating Drug, Biologic and Medical Device Regulatory Strategies

Contributing Author: Mamta Puri-Lechner In a recent webinar, Kanchana Iyer and Mamta ...
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Daniel SmithMar 12, 2025 10:21:13 AM1 min read

FDA Announces Key Transition Dates for ESG NexGen

Halloran participated in the User Acceptance Testing last summer/fall and is excited ...
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