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.
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...
Publishing an eCTD Clinical Study Report: ICH E3
August 15, 2017 | B J. Witkin, Senior Manager | Regulatory Operations Because IMPACT writes and publishes so many CSRs, we get a lot of sponsors asking us questions about how CSRs should be published. This tells me that there’s a lot of confusion about CSR...
What Skills Do You Need to Be a Good Regulatory Medical Writer?
August 25, 2016 | Kim Nice, PhD, Associate Director, Medical Writing and Submissions Management | Medical Writing Services In previous posts, you were introduced to the role of regulatory medical writing and heard about the day-to-day activities of a regulatory...
What Does a Regulatory Medical Writer Do All Day?
August 11, 2016 | Nancy Smith, PhD, Senior Manager, Medical Writing and Submissions Management | Medical Writing Services In my last post, I explored my transition from the bench to regulatory medical writing. I knew little about medical writing when I started, but...
Planning Your NDA or BLA Submission: It’s More Than a Gantt Chart!
February 25, 2016 | Tim Garver, PhD, Executive VP and Chief Operating Officer | Medical Writing Services You’re finally there! You and your colleagues find yourself at the doorstep of being able to submit either a New Drug Application (NDA) or Biologic License...
Top Two Things I Learned at DIA RSIDM
February 18, 2016 | B J. Witkin, Senior Manager | Regulatory Operations I recently attended the DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) forum, an annual conference for people who work in Regulatory Operations and Regulatory...
Formal Meetings with FDA for Biosimilar Products
February 10, 2016 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting Yeah, yeah, we know. The general public considers biosimilars to be “generic” versions of approved biological products. The FDA has gone to...
How to Make Publishing Clinical Summaries Easier
February 4, 2016 | BJ Witkin, Senior Manager | Regulatory Operations One of the biggest challenges of publishing an NDA, MAA or BLA is dealing with the clinical summaries: the Summary of Clinical Safety (SCS), the Summary of Clinical Efficacy (SCE), the Integrated...
Direct-to-Consumer Advertising of Prescription Drugs
August 20, 2015 | Mark Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs We’ve all seen or heard them - either in popular magazines and newspapers or on television and radio - advertisements directed to us, the consumers of prescription medications....
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