Meranda Parascandola - DSI InPharmatics

February 17, 2022

Published by Meranda Parascandola at February 17, 2022

DSI Welcomes a New Director of Business Development

DESIGN SPACE INPHARMATICS (DSI) ANNOUNCES APPOINTMENT OF BEN LUTS AS DIRECTOR OF BUSINESS DEVELOPMENT (Harleysville, PA; February 1, 2022) – Design Space InPharmatics (DSI), a full-service CMC consulting firm focused on providing pharmaceutical attributes, regulatory affairs, and drug discovery and development consulting services, is delighted to announce today the appointment […]

February 25, 2022

Published by Meranda Parascandola at February 25, 2022

DSI Announces Virtual Attendance of BIO Europe Spring 2022, March 28-31

DSI plans to attend the 2022 BIO Europe Spring conference virtually. Our new Director of Business Development, Ben Luts, will be joining the conference on behalf of DSI. To set up a meeting with Ben, contact him at bluts@dsinpharmatics.com or through the partnering site. Whether you’ve used our services in […]

March 2, 2022

Introduction to Chemistry, Manufacturing, and Controls (CMC) Regulatory Strategy

Published by Meranda Parascandola at March 2, 2022

When Decisions Decide the Outcome

Beginning with spring training through the dog days of summer to the stretch drive, every decision on and off the field can affect the postseason outcome.

March 23, 2022

Published by Meranda Parascandola at March 23, 2022

API PROCESS VALIDATIONS: A Broadway Analogy by Jim Mencel, PhD

Before the stage is set and the curtain rises for a debut performance, the time-consuming process of putting together a Broadway show is the perfect analogy used by Jim Mencel, Senior Drug Substance Consultant at Design Space InPharmatics, to describe process validation for Active Pharmaceutical Ingredients (APIs) when preparing for filing with the FDA.

April 6, 2022

Published by Meranda Parascandola at April 6, 2022

Nitrosamine Assessment

The FDA has been investigating the presence of nitrosamine impurities in certain drug products. Since 2018, several drug products including ARBs, ranitidine, nizatidine, and metformin have been found to contain unacceptable levels of nitrosamines. Nitrosamines are classified as probable human carcinogens based on animal studies and there has been a pressing need to remove the risk to patients.

April 20, 2022

Published by Meranda Parascandola at April 20, 2022

Virtual Audits: A Digital-First Frontier

In the era of the coronavirus pandemic, all aspects of life were shown to have had the rug pulled out from underneath them. Each facet of our working and personal lives has gone remote. This virus put an end to travel and in-person work processes. Looking at pharmaceutical companies, there was a need to adopt virtual options to complete critical processes by the corporations and outsiders’ involvement.