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.
Potency Assurance for Cellular and Gene Therapy Products
16 Apr 2024 | Renee Boerner, Dave Malliaros, Norris Pyle One of the many challenges around developing cell and gene therapy products is establishing representative potency methods. In 2011, the FDA released the Guidance for Industry: Potency Tests for Cellular and...
Conducting Clinical Trials in Australia
05 Apr 2024 | Nate DiTommaso, Rachel Capone, Renee Boerner Have you ever wondered why some companies choose to do their first in human clinical trials in Australia? Are there any real advantages or are people just looking for an excuse to go to the ‘Land Down Under,’...
Syner-G Solutions To Navigating Medical Writing From Home
28 March 2024 | Olivia Rivera, PhD and Yael-Natalie H Escobar, PhD When COVID-19 shut down workplaces, remote work became the norm for many, including medical writers. Now, in a post-pandemic world, many medical writers continue working from home, finding their daily...
Shortening the Timeline: A Medical Writer’s Guide to Success
25 Mar 2024 │ Christina (Chrissy) Williams, PhD, RAC, Sr Director │ Medical Writing Services How can we shorten the timeline? Clinical and regulatory medical writers often hear that question on repeat. There’s the obvious answer…provide on-time, high-quality, clean...
Writing with Style: Why styles are important in medical writing
05 Mar 2024 │ Euan Griffiths, Senior Quality Control Specialist │ Medical Writing Services When we think of medical writing, style is not the first thing that springs to mind. It is, however, crucial to ensure quality and consistency within a document, as well as...
Regulatory Medical Writing: What Is It and What Do They Do?
Welcome to the essential yet often behind-the-scenes world of regulatory medical writing. This field stands at the crossroads of science and communication for the approval of new medical treatments. Regulatory writers are the linchpins in this process, tasked with...
Prescription for Success: Streamlining Meetings to Craft Compelling Regulatory Documents
February 29, 2024 | Evan DuBose, PhD and Kelsey Gray, PhD – Clinical Research Scientists | Medical Writing Services Does scheduling meetings feel like a circus act between juggling multiple calendars and balancing competing priorities? If so, you will likely...
Syner-G’s Medical Writing Fellowship Program: Preparing Professionals for a Career in Regulatory Medical Writing
February 16, 2024 | Yash Patel, PharmD, Yamini Purohit, PhD, and Kelsey Gray, PhD – Medical Writing Fellows | Medical Writing Services Regulatory medical writers play a key role in facilitating the development and compilation of documents that are submitted to...
Useful Tools to Facilitate CDMO Selection Process for Biologics
Selecting a Contract Development and Marketing Organization (CDMO) is not a new topic, and much has been written and learned since CDMO’s first started to become an option in the late 1990s. If the decision is to outsource, selecting a CDMO partner remains one of the...
Advice for First Time NDA/BLA Submission Teams
Our team of medical writers has worked with many clients on marketing applications (e.g., NDA, BLA, or MAA) across a variety of therapeutic areas. Each submission is a challenge in its own unique way, but we have found that the most exciting projects to work on are...
Headquarters
100 Pennsylvania Avenue, Suite 310
Framingham, MA 01701
Contact Us
508.460.9700
info@synergbiopharma.com