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June 9, 2025  •  Whitepaper

A Roadmap of Drug Development and Analytical Method Progression

Drug Development is a complex and lengthy process that requires extensive testing and characterization of the molecule to ensure safety, efficacy, and potency of the molecule. One crucial aspect of this process is analytical method development and validation. Analytical method development is the process…

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May 19, 2025

Combination Products Part 4: Human Factors in Combination Products

Watch our fourth combination products’ webinar, “Human Factors in Combination Products” presented by Anchal Choudhuri

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May 6, 2025  •  Podcast

Navigating CMC and Nonclinical Challenges with Novel Cell and Gene Therapy Products

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April 4, 2025

Beyond Gene Replacement Strategies: Safety Considerations for Novel AAV Vector Modalities

Adeno-associated virus (AAV) vectors have been widely leveraged in gene therapy, and currently a number of products, including Luxterna® and Zolgensma®, have already been approved for gene replacement therapy using AAV vector technology.  To date, AAV vectors have been the workhorse of gene therapy…

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November 15, 2024  •  Webinar

Combination Products Part 2: Considerations for Delivery Device Companies

Watch our second combination products' webinar, “Considerations for Delivery Device Companies” presented by Anchal Choudhuri and Christina Vessely.

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July 22, 2024  •  Webinar

Combination Products: Integration of Drugs and Delivery Devices

Watch our first combination products' webinar, “Integration of Drugs and Delivery Devices” presented by Anchal Choudhuri and Christina Vessely.

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July 10, 2024  •  Webinar

How to Elevate Your Nonclinical Safety Data Review and Decision Making

Watch our on-demand webinar, “How to Elevate Your Nonclinical Safety Data Review and Decision Making” presented by Bruce Pearce, David Pepperl, Chris Scull and Laurie Iciek.

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April 16, 2024

Getting Out of Trouble, with Chris Vessely

When you have an anomalous lab result, you just might be in trouble. However, Chris Vessely can help you close the case of what went wrong, help you find a way to save the day, and help keep you from getting in trouble in the first place.

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March 15, 2024  •  Webinar

New FDA CAR-T Guidance: What Sponsors Need To Know

Watch our on-demand webinar, "New FDA CAR-T Guidance: What Sponsors Need To Know"

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January 12, 2024  •  News

Biologics Consulting Announces Regulatory Affairs Business Unit

Biologics Consulting is thrilled to announce

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