The GLOBAL Perspective

GLOBAL Employee Interview with the Med Device Team

Learn tips and tricks about team resourcing from our Medical Device Senior Managers Beth Meier and Luke Baker.

IND Top Tips with Julie Moon

We sat down with Julie Moon, an expert in CMC and our BD Director. She shares top tips for a successful IND submission.

4 Practical Tips for Better Technical Writing in the Life Sciences

Here are four essential tips that elevate your technical writing and help ensure your documents hit the mark every time.‍

A Clear Path to the Clinic and Beyond: Why Getting Your IND Submission Right Matters

Tips on how to avoid submission delays and improve your IND submission process.

How Do You Know When You’re Ready to Submit an IND? Part 2

How to determine if you need a pre-IND meeting, how to prepare, and other ideas to move forward with confidence.

How Do You Know When You’re Ready to Submit an IND? Part 1

Read about the core requirements for a successful IND submission, the strategic advantages of scheduling a pre-IND meeting, and how to prepare in a way that not only streamlines the review process but also reduces the risk of encountering a clinical hold.

Common Team Building Mistakes in Regulatory Writing Teams

5 common mistakes in building a team and how they can impact your team's performance.

Hiring the Right Medical Writer

Four areas to consider when hiring a medical writer.

Managing Resourcing for Regulatory Writing Teams in the New Year

Eight key areas to consider when resource planning for regulatory writing teams.

AI-Powered Submission Authoring for Module 3 and Beyond: Introducing RegWriter

How RegWriter™ can improve your regulatory submission process.

PSURs: Obstacles with Pending MDR Approval

Tips on how to navigate challenges when writing PSURs.

The Challenges of Using AI for Medical Device Adverse Event Categorization & Reporting and How to Overcome Them

Explore challenges with AI in the medical device industry and explore practical solutions.

Overcoming the Challenges of Complaint Reporting with IMDRF Adverse Event Terminology

The IMDRF framework offers a solution to challenges associated with complaint reporting by providing a standardized set of terminologies for adverse event reporting, streamlining processes, and improving the accuracy of reported data.

Tips for a Successful eCTD Submission

Explore tips from the GLOBAL team for a successful eCTD submission.

Gertrude Elion: A Pioneer in Cancer Research and the Development of Life-Saving Medications

Gertrude Elion was a trailblazer in scientific innovation through her lifelong commitment to medical research and the treatment of cancer and disease. Learn more about her as part of our Women in Science Series!

GDUFA: Its impact on the Type II Drug Substance Drug Master File (DMF)

This post highlights some FDA initiatives undertaken to enhance the DMF review process and provide guidance to the pharmaceutical industry, in light of GDUFA.

Artificial Intelligence and the Pharmaceutical Industry

According to a recent review in Drug Discovery Today leading pharmaceutical companies are in an ‘early mature’ phase of using AI in research & development (R&D). Learn more in this post!

The Use of Neutral, Unbiased, and Equitable Language in Medical Writing

It is increasingly important in medical writing to recognize diversity in race and ethnicity, sex and gender, sexual orientation, socioeconomic status, and disability, and to avoid assumptions about a patient’s identity or medical condition.

The CTA Process Under Regulation (EU) 536/2014: Why Flexible Writing Solutions Are Needed

European Commission, Regulation (EU) No. 536/2014 is challenging the status quo when it comes to clinical trial writing solutions.

5 Scientifically Accurate Horror Movies

Celebrate spooky season with 5 scientifically accurate horror movies selected by the GLOBAL team.

Far UV-C and Coronavirus Disinfection News in 2024

Research is growing in the area of rapid, safe limitation of airborne and surface viral transmissions, and one usage is a type of ultraviolet (UV) light device for disinfecting surfaces and objects.

Florence Nightingale Shaped COVID Care

Learn more about how Florence Nightingale helped us through early COVID pandemic response as part of our Women in Science Series!

Women’s History Spotlight: June Almeida

You might not recognize the name June Almeida, but you’ve likely seen her work. Learn how she became known for her work with electron microscopy and perfecting the negative staining technique in our Women in Science Series.

M. Joycelyn Elders: Breaking Barriers as a Trailblazing Pediatrician and Public Health Administrator

M. Joycelyn Elders rose to prominence as an influential pediatrician and public health advocate, and she served as the first black woman appointed Surgeon General of the United States. Learn more as part of our Women in Science Series.