Meranda Parascandola - DSI InPharmatics

December 11, 2017

seven misunderstood facts about regulatory drug development consulting

Published by Meranda Parascandola at December 11, 2017

7 Reasons to Hire Regulatory Drug Development Consultants

“Why should I hire a consulting firm? I can just do it myself!” This statement is often made without a complete understanding of the real value provided by Regulatory Drug Development Consultants (RDDC). An effective consulting firm is there to supplement your business proceedings, never to imply that they know better than you do.

November 9, 2018

Published by Meranda Parascandola at November 9, 2018

5 Key Traits That Separate Subject Matter Expert Consulting Firms from the Pack

There are far too many mediocre Consultants out there. Perhaps their objective isn’t strictly to take up your time and drain your wallet, but that’s what it can feel like. Working in the pharmaceutical consulting arena requires unique expertise that can be passed on through the work performed on a daily basis.

January 6, 2019

Published by Meranda Parascandola at January 6, 2019

2019 J.P. Morgan Health Care Investor Conference

Each year, healthcare, pharmaceutical, and biotechnology executives attend the JP Morgan Healthcare Conference, some to tout recent developments, others just to bounce from session to session.

March 7, 2019

Published by Meranda Parascandola at March 7, 2019

FDA Unveils Plan for Draft CMC Guidance in 2019

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue new draft and revised draft quality/chemistry manufacturing and controls (CMC) guidance documents spanning different categories, from biosimilars to microbiology to Pharmaceutical Quality, in 2019.

March 8, 2019

Published by Meranda Parascandola at March 8, 2019

DSI Sponsors DCAT in NYC

DCAT is the premier business development event for companies engaged in pharmaceutical development and manufacturing and related industries. Held annually in March, DCAT Week ensures that members have a forum for high-level strategic meetings with key decision makers, timely educational programs, and important networking opportunities.

March 28, 2019

Published by Meranda Parascandola at March 28, 2019

Preparing for an FDA End of Phase II (EOP2) CMC Meeting

Three rules of engagement are recommended to take place at an End of Phase II meeting, either face to face or by telephone. Each rule helps to ensure a successful negotiating strategy based on the actual discussions with the Agency.