Blog | DSInpharmatics

January 7, 2023

Published by Meranda Parascandola at January 7, 2023

Chemistry, Manufacturing and Controls (CMC) for Cell & Gene Therapy (CGT) Products

Cell and gene therapies for treating multiple myeloma, such as CAR-T, have resulted in breakthrough health outcomes for patients. In the last decade, approval of cell and gene therapy (CGT) products has increased significantly. Multiple other products are in clinical development for solid tumors, genetic deficiencies, and infections that promise more effective […]

February 10, 2023

Published by Meranda Parascandola at February 10, 2023

A New Chapter in Clinical Trials: The Mandatory CTIS and Its Impact – Insights by Randall Lis

Navigating the New Frontier of Clinical Trials! Randall Lis shares expert insights on the mandatory CTIS implementation, revolutionizing the EU clinical research landscape. Explore the key trends, benefits, and challenges shaping this transformative journey

February 24, 2023

Published by Meranda Parascandola at February 24, 2023

How Regulatory Affairs Consultants Could Help Your Company

Drug development is an immensely complex undertaking consisting of many different, interconnected processes. Specialist regulatory affairs consultants offer services to companies operating across this challenging industry. Pharmaceutical companies and the drugs they develop must meet stringent regulations before products are approved for the market. Continue reading to learn how regulatory […]

February 24, 2023

Published by Meranda Parascandola at February 24, 2023

Medical Device Consulting For Worldwide Regulatory Applications

Global healthcare systems require medical devices that are safe and effective in the diagnosis, treatment and prevention of diseases, and physicians rely on a wide range of medical devices to help identify and treat said ailments. However, for medical devices to be considered both safe to use and effective for […]

February 27, 2023

Published by Meranda Parascandola at February 27, 2023

How Drug Development CMC Works

When pharmaceutical companies develop a new drug product for the market, there are many different steps a potential product must go through to determine and control its safety, manufacturability, effectiveness and reliability. These processes, and all activities within, are known as chemistry, manufacturing, and controls (CMC). CMC is done during […]

March 22, 2023

Published by Meranda Parascandola at March 22, 2023

BARDA Program Proposal Production and Contract Management

The Biomedical Advanced Research and Development Authority (BARDA) is) probably best known for its role in Operation Warp Speed and subsequent efforts to accelerate the manufacturing of COVID-19 vaccines. BARDA, formed in 2006, anticipated threats such as the COVID-19 pandemic. BARDA’s mission is to develop the necessary response measures to […]

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