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December 11, 2017

seven misunderstood facts about regulatory drug development consulting

Published by DS Inpharmatics 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 3, 2019

Published by DS Inpharmatics at January 3, 2019

Our Blog

Since regulatory is an experience-based profession, success is guided by one’s ability to learn from multiple experiences across various projects at different stages of development, which provides an understanding of basic principles that can then be applied to the decision making required for a specific project. Welcome to the our Blog.

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 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.

April 16, 2019

Published by Meranda Parascandola at April 16, 2019

How a Falling Apple Inspired the Understanding of Gravitational Force

The young Isaac Newton is sitting in his garden when an apple falls on his head and, in a stroke of brilliant insight, he suddenly comes up with his theory of gravity. The story is almost certainly embellished, both by Newton and the generations of storytellers who came after him. But from today anyone with access to the internet can see for themselves the first-hand account of how a falling apple inspired the understanding of gravitational force.