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 […]

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 […]

May 4, 2023

Published by Meranda Parascandola at May 4, 2023

SaMD (Software as a Medical Device) and Reflecting on EU MDR Compliance

Diagnosing illnesses and monitoring health is increasingly reliant on utilizing software. For patients, manufacturers must maintain standards and regulations. Companies can be concerned with challenges concerning updated legislation such as the EU’s MDR. Companies have increased importance on determining whether their software is categorized as a medical device, as well […]