Newsletter | May 7, 2024

05.07.24 -- New Initiative Seeks To Back Up ICH's Harmonization Mission

SPONSOR

Clinical Research As A Delicate Ecosystem

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FEATURED EDITORIAL

New Initiative Seeks To Back Up ICH's Harmonization Mission

An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.

INDUSTRY INSIGHTS

Integrating Early-Phase Clinical Supply Manufacturing And Distribution

A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development, CTM manufacturing, and supply and distribution to patients.

3 IRT Tactics Being Used To Streamline Supply Logistics

Shipping and storing leading-edge therapeutics require complex logistics, but enhanced automation and process simplification ensure that sites and patients have the drugs they need when they need them.

Consolidating Clinical Supply Chain Operations With GxP Inventory

A Japan-based biotechnology company leveraged Signant SmartSignals® GxP Inventory, which improved visibility, reduced risks and costs, and optimized operations in this case study.

SOLUTIONS

Guiding A Combination Product Down The Path To Regulatory Submission

Scalable Manufacturing Of Sterile Drug Products

24/7 Cell & Gene Control Tower Proves Agile Solution For Critical Shipments