Meranda Parascandola - DSI InPharmatics

April 1, 2021

Published by Meranda Parascandola at April 1, 2021

Establishing Regulatory Starting Materials & Understanding the ICH

There are many ways for companies to get approvals for expedited development. This is primarily based on trials and data from clinical studies. The biggest issue has always been how acceleration impacts CMC. In many cases, the data and the programs need time and cannot be expedited. So how do you ensure CMC doesn't become the bottleneck?

April 15, 2021

Published by Meranda Parascandola at April 15, 2021

Material Characterization and Formulation Development

Learn how to guide sponsors in the critical exercise of materials characterization and the establishment of reference standards for NCEs as well as in the formulation of drug products from the IND-enabling stages of development through postapproval evergreening changes.

April 28, 2021

Published by Meranda Parascandola at April 28, 2021

DSI Announces Its Acquisition by ProductLife Group

(Harleysville, PA; April. 28, 2021) – We could not be more pleased to become part of a global leader in the life sciences regulatory and compliance industry. Joining PLG is exciting both for DSI as a business and for our clients, who will now have access to additional specialist expertise […]

May 14, 2021

Published by Meranda Parascandola at May 14, 2021

DSI Announces Virtual Attendance of Bio Digital 2021, June 14-18

DSI announced today that it will be actively engaged in partnering meetings during the BIO International Convention. The 2021 BIO International Convention will transition to a virtual event format, BIO Digital. This virtual gathering of the global biotech industry provides access to partners via BIO One-on-One Partnering and educational resources. […]

June 3, 2021

Published by Meranda Parascandola at June 3, 2021

Meetings Between the FDA and Sponsors Aren’t Quite What You Think They Are

FDA Meetings aren’t what many people think they are especially when it comes to the CMC-focused discussions. We look at seven common opinions about formal meetings between the FDA and Sponsors or Applicants of PDUFA Products when it comes to CMC compliance and compare them to reality.

June 17, 2021

Published by Meranda Parascandola at June 17, 2021

The Analytical Detective: Understanding Impurities in the Molecule Assessment Process

Colman Byrne, a senior analytical services expert at DSI, describes the molecule assessment process as detective work, in which physical chemists assess different pieces of information to solve a puzzle. Questions that must be answered in the process include: What is the product supposed to be and do?