Halloran Consulting Group, Inc.

?? Meet the Experts Behind the GCP E6 (R3) Webinar! ?? Get ready for an insightful session with our expert speakers who will guide you through the evolving world of clinical trial quality and compliance. These industry leaders will break down the latest updates to GCP E6 (R3) and share practical steps to implement digital-first quality strategies in your trials. ?? Register Now https://hubs.la/Q03chqs50 #ClinicalTrials #Compliance #GCP #DigitalTransformation #Webinar #HalloranCG

Join Dr. Mamta Puri-Lechner and Kanchana Iyer, Senior Consultants at Halloran Consulting Group, for an insightful webinar on "Navigating Regulatory Strategies for Drugs, Biologics, and Medical Devices" on March 18th from 12:00-1:00 PM EST. Seize the chance to learn from industry leaders and fast-track your product's journey to market. Still time to sign up... ?? Register Today! https://hubs.la/Q03bntsR0 #RegulatoryStrategy #ConceptToCommercialization #HalloranCG

??NEW WEBINAR ?? Are You Ready for the Impacts of ICH GCP E6 (R3)? The world of clinical trials is evolving, and so is Good Clinical Practice (GCP). Join us for an exclusive webinar diving into the updates of GCP E6 (R3) and how digital transformation is reshaping the industry. ??Don’t miss out— Register Now! https://hubs.ly/Q03bLMxZ0

Go virtual. What do we mean by that? Well, when Publishers work on PDF documents, any job that ties up Adobe Acrobat for a few minutes to even 1 hour will have your Reg Ops team at a standstill as they cannot work on another PDF while the other job is processing. For example, Clinical Study Report Tables, Listings and Figures (TLFs) can be a bear for Adobe to quickly save or even convert to Rich Text Format (RTF) files to PDF. These activities often require Adobe to run multiple hours or overnight which ties up Adobe and does not permit the publishers to begin working on other documents leaving your publisher at a standstill. What do you do? Talk to your IT team. Ask them to set up a virtual machine for the Reg Ops team to log onto when these situations arise to allow them to continue to work. It is beneficial to have this second, virtual computer available to run the processing or these 40k page files in the background while enabling the publisher to move onto other documents within the submission build and maintain submission timelines. Learn more about Halloran can streamline your processes https://hubs.la/Q03bnpMJ0 #VirtualSolutions #HalloranCG #RegulatoryOperations

The FDA’s new ESG NexGen platform is set to go live in 2025. Halloran participated in the User Acceptance Testing and is excited to support our clients with this modernized, cloud-based interface. ?? Read our blog by Dan Smith, Associate Principal Consultant, Regulatory Operations, to learn more about the upcoming transition and what it means for your submissions. https://hubs.la/Q03bv15z0 #ESGNexGen #FDA #HalloranCG #blog

Join Mamta Puri-Lechner, Ph.D. and Kanchana Iyer, Senior Consultants at Halloran Consulting Group, for the webinar "Navigating Drug, Biologic, and Medical Device Regulatory Strategies" on March 18th, 12:00-1:00 PM EST. Don’t miss this opportunity to hear from industry experts and accelerate your product’s path to market. ?? Register Now https://hubs.la/Q03bnq6K0 #RegulatoryStrategy #ConceptToCommercialization #HalloranCG

Halloran on The Issue Podcast! ??? Nicole (Niki) Gallo, RAC, Principal Consultant at Halloran Consulting Group, joins American Society of Gene & Cell Therapy on "The Issue" podcast to dive deep into timeline management, INDs, and the ever-evolving FDA landscape. Gain valuable insights as she shares her expertise on navigating the regulatory processes for innovative therapeutics. You won’t want to miss it! ??Listen Now https://hubs.la/Q03bhdsq0 #HalloranCG #RegulatoryAffairs #FDA #InnovativeTherapeutics #Podcast

??Halloran Consulting Group is proud to sponsor the MSU Denver Breadth in Bioscience Symposium! Join us for an incredible networking event and hear from Halloran’s Shawn Roach, Associate Principal Consultant, CMC, as he shares insights into his career journey in life sciences. Learn more and stream the event here! https://hubs.ly/Q03bb2G60 #Bioscience #Networking #HalloranConsulting #MSUDenver #Keynote #LiveStream

Sponsors can never share too much information with Health Authorities. The more data you provide the Review team throughout the drug development process during key engagement meetings, the greater the collaboration will be the Agency. This not only helps with building trust equity fostering a positive relationship, but it also allows the regulators opportunity to disclose their perspective on approaches the sponsor is taking. Regulatory strategy should always involve derisking the application from not only refuse to file issues but deficiencies that could surmount to the unfortunate Complete Response. One of the ways this is achieved is by being as transparent as possible with the Health Authority. Learn More https://hubs.ly/Q039GWHR0 about Halloran’s services and solutions. #PharmaDevelopment #RegulatoryStrategy #HalloranCG

Do you want to minimize the chances of failure during the clinical trial process? Do you want to save significant time, money, and resources by identifying potential issues early on and improve the likelihood of a successful outcome and ultimately bringing a new treatment to patients faster and more efficiently? Read Pam Vizanko’s Pathway to Success: How De-Risking Life Sciences Companies Leads to Investment Growth https://hubs.la/Q039k1vB0 based on her experience attending Biocom California's 15th Annual Global Life Science Partnering & Investor Conference and on how Halloran can help you de-risk your product development. #BiocomGPIC