Meranda Parascandola - DSI InPharmatics

August 26, 2022

Published by Meranda Parascandola at August 26, 2022

DS InPharmatics Announces Attendance of Biopharm America 2022, September 28-29

Join the DSI team in Boston on September 28-29, 2022 at Biopharm America! We’re excited to be back in-person at BPA this year. For 2022, the conference is also providing two virtual days, October 4-5, 2022, for those unable to attend the conference in-person. We will be participating in the […]

August 30, 2022

Published by Meranda Parascandola at August 30, 2022

How Pharma Companies Manage Commercial Supply Chains

The pharmaceutical supply chain is a complex network of processes that must work together to ensure patients receive vital medicines promptly and safely. Supply chains can be challenging, but managing them well is the key to successful pharmaceutical business.

September 23, 2022

Published by Meranda Parascandola at September 23, 2022

DS InPharmatics Announces Virtual Attendance of BIO Europe 2022, October 24-26

DSI’s recent acquisition by Paris-based Product Life Group (PLG) has granted the company options to further expand into the European market. We hold prior experience in Europe and ROW and are excited to explore more opportunities in these regions. The addition of PLG’s resources and support will allow the DS […]

October 14, 2022

Published by Meranda Parascandola at October 14, 2022

What Is An Investigational Device Exemption Application and Study?

An Investigational Device Exemption (IDE) is an application submitted to obtain the FDA's approval for use of a novel medical device in a clinical study. This allows for the collection of safety and effectiveness data in order to support full market approval. IDE applications support several types of studies: to […]

January 6, 2023

Published by Meranda Parascandola at January 6, 2023

Your Company’s FDA Meeting Survival Guide

Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.

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 […]