Blog
All our Blog posts can be found here, listed in chronological order beginning with the most recent post. To access blogs on specific topics, use the links below.
Overview of FDA Expedited Development and Approval Programs for Serious Conditions
May 4, 2022 | Nathaniel DiTommaso, MS, Regulatory Affairs Manager In May of 2014 and February of 2019, the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and...
The Push for Patient-Focused Drug Development
January 10, 2022 | Julia DiFiore, PhD | Clinical Research Scientist Many of us involved with drug development derive a lot of satisfaction in knowing that our work contributes to improving the health of patients around the globe. We offer our insight and expertise...
Keep ’em Coming: An Overview of IND Updates
June 2, 2020 | Kathryn Tworkoski, PhD, RAC | Principal Clinical Research Scientist In the past, we’ve written blog posts explaining what an Investigational New Drug (IND) is, providing guidance on pre-IND meetings, and outlining the submission and maintenance of...
From Benchtop to Desktop: 8 Transferable Skills Learned in the Lab that Apply to Medical Writing
October 30, 2019 | Brandi Schuster, PhD, Clinical Research Scientist | Medical Writing Services So you’ve decided to begin a career in medical writing - congratulations! Now what? It may be scary leaving the comfort of your lab and pipettes, and medical writing may...
Statistics in Harmony: The Role of Estimands in Regulatory Writing
February 25, 2019 | Cheryl Ainslie, PhD, Clinical Research Scientist II | Regulatory Affairs Services In a previous post, I summarized the process by which the International Council for Harmonisation (ICH) creates harmonized guidelines for use by the pharmaceutical...
Current Topics in Orphan Drug Development
December 14, 2018 | Kathryn Tworkoski, PhD, RAC, Senior Clinical Research Scientist │ Regulatory Affairs, Medical Writing, Drug Development Consulting Long-time readers of this blog will recall (with great enthusiasm, I’m sure) our previous posts on rare diseases,...
The Why, What, When, Who, and How of Quality Control (QC) of Medical Writing Deliverables
May 15, 2018 | Nancy Gasper-Smith, PhD, RAC, Consultant, Medical Writing and Submissions Management and Head of Quality Control │ Medical Writing Services Quality control (QC) is a term that applies across many industries. Within the field of regulatory medical...
Ready to Submit Your Initial IND?
April 20, 2018 | Kasturi Puranam, PhD | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting I hope that you have read our previous blog posts on IND filing and have learned about the types of INDs, when you need to file an IND, and pre-IND...
Before you file your IND…
March 14, 2018 | Preeti Chugha, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting You’ve determined that you need to file an IND to conduct human trials in the US. What do you need to do before you submit your IND? While INDs...
The Ins and Outs of INDs
February 16, 2018 | Kathryn Tworkoski, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting Introducing a new therapeutic agent to human patients can be simultaneously exciting and nerve-wracking. Over the years, we’ve had a lot...
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