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.

May 19, 2022

Published by Meranda Parascandola at May 19, 2022

DSI Announces Attendance of BIO International 2022, June 13-16

DSI announced today that it will be actively engaged in partnering meetings during the BIO International Convention. The 2022 BIO International Convention will transition to a virtual and in-person (optional) event format. This virtual gathering of the global biotech industry provides access to partners via BIO One-on-One Partnering and educational […]

June 1, 2022

Published by Meranda Parascandola at June 1, 2022

Virtual Audits: How to Provide Objective Evidence to Support Quality Medical Devices

Audits are necessary. However, just as we learned during the COVID-19 pandemic, that many people could perform their jobs perfectly well without getting in their car or on a train to come to the office, we have also seen that many audits can be done well…virtually. There is a place for both virtual and on-site audits.

June 1, 2022

Published by Meranda Parascandola at June 1, 2022

The Parenteral Drug Association and Impact of Microbiology

Episode 25 of CMCLive delved into the PDA- the Parenteral Drug Association, going in-depth as to what this association is with microbiology expert Mike Carroll. Carroll, having over 30 years in the pharmaceutical field under his belt leads to a wealth of knowledge about the field of microbiology.

June 7, 2022

Published by Meranda Parascandola at June 7, 2022

FDA-Required Medical Device Regulations

Medical devices have been saving lives for decades. And medical devices are quickly changing as new technology such as 3D printing, software, hardware and algorithms are being incorporated into device designs. Medical devices are not simply band aids and thermometers any longer. They are sophisticated designs that help people with a myriad of problems and in many cases, they prolong and save lives.

August 3, 2022

Published by Meranda Parascandola at August 3, 2022

Understanding the Relationship Between CMC & GMP

CMC information reinforces the connection between the quality of a candidate drug used in clinical studies and the end product marketed to consumers. It effectively outlines critical quality attributes across the full life cycle of drug products, from clinical development to commercial scale production. Like current good manufacturing practices (cGMP, or GMP), CMC reviews have regulatory requirements established by the US FDA. But where the goals of these two pharmaceutical control strategies are closely aligned, they differ significantly in approach and regulation.

August 8, 2022

Published by Meranda Parascandola at August 8, 2022

How Global Regulatory Strategies Create Pathways for Medical Devices

You've likely heard the phrase “time is money.” No other statement could be more accurate for the medical device industry. Each day your company is not approved to market your device is not only a day of lost revenue, but a day patients don’t get to benefit from the value […]