Regulatory Odd Couple Series

July 23, 2020
Published by Meranda Parascandola at July 23, 2020

The Odd Couple – Part 5: Authoring the Container Closure Systems for Packaging of Drug Substance and Product Modules

Container closure systems refer to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. The packaging information in the chemistry, manufacturing, and controls section usually includes a description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance and drug product during their use.
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August 13, 2020
Published by Meranda Parascandola at August 13, 2020

The Odd Couple – Part 7: Authoring the Composition and Pharmaceutical Development Modules

Pharmaceuticals (both Synthetically and Biotechnology-derived) are being developed by many sponsors whose management teams have varying degrees of familiarity or experience with the regulatory requirements for these challenging products.
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July 29, 2026
Published by DSI Subject Matter Experts at July 29, 2026

Achieving Global CMC Alignment: Why Harmonized Regulatory Strategy Is the New Competitive Advantage

Preparing CMC packages for a single regulatory agency is already a technically demanding effort. Preparing them for multiple regions each with its own expectations, formats, and scientific emphases is an entirely different challenge. As sponsors increasingly pursue simultaneous submissions in the U.S., EU, and international markets, achieving true global alignment […]
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