September 19, 2017

12 Reasons You Should Invest in Biotech Consulting

Biotechnology firms are cropping up all over the place, and growing at an unbelievable rate. California alone is home to over 3,000 life sciences companies, employing over 287,000 people[1] and the global industry is expected to be worth $727.1 billion by 2025.[2]
December 11, 2017
seven misunderstood facts about regulatory drug development consulting

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
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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
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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.
February 14, 2019

Your FDA Meeting Survival Guide Has Arrived

Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.
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.