The Roundtable Dinner is Back!

EU Clinical Trial Regulation

A profound change was finally realized in January 2022 when the European Union’s Clinical Trial Regulation (CTR) entered into application with the “go live” of the Clinical Trials Information System (CTIS). (more...)

Accelerating medical device regulatory approvals with clinical trial site operations.

Notified Body interactions during the review of technical documentation remediated to MDR and IVDR

Regulatory Intelligence – Medical Devices

 As product designs, development, and manufacturing change get more innovative, regulatory authorities have also become proactive and alert to guarantee medical device safety and effectiveness. (more...)

FDA medical device regulations and Submissions 

Combination Product Design Controls/QbD—Does it apply to you?

Do you work in the pharmaceutical or biotech industry? Do you or your organization play a key role in new or sustaining combination product development projects?  (more...)

Manna from Heaven - PDUFA VII

Drug Approval Process for generic products, and GDUFA program

Toxicology FAQs 

Advanced Therapies – Lessons learned from regulatory challenges

 Advanced therapies are one of the fastest growth sectors in the biopharmaceutical industry. Several factors contribute or pose unique challenges for the development of these highly innovative products including: (more...)

Premarket Safety Analysis with FDA Medical Queries (FMQs)

Industry professionals often rely on medical queries to characterize adverse events for premarket safety assessment and for postmarket surveillance.  In the premarket setting, investigators utilize Preferred Terms and the over-arching Standardized MedDRA Queries (SMQ) to (more...)

Making the Switch: Transitioning your career into Regulatory Writing

Are you at a career crossroads? Have you ever considered Regulatory Writing? Very few people enter the field on a direct path but (more...)

The Logistics of Starting Your Own LLC/Consulting Company

 In this discussion, we will talk about the steps necessary for starting an LLC in North Carolina, the potential benefits of filing your LLC as an S corporation, and some of the pros and cons (more...)

Regulatory Affairs Influence in Investment Decision-making

Some may think of regulatory affairs as just a box-checking requirement or a paperwork-heavy burden, but did you know that it’s also foundational for the multimillion-dollar financings that fuel biopharma companies? (more...)

Storytelling, Hypnosis, and Vulcan Mind Melds:  The Art and Science of Persuasion in Regulatory Interactions

Influence and persuasion are key skills for successful interactions and negotiations with regulatory authorities. While extensively data-driven, regulatory documents are inherently persuasive in objective and function. (more...)