Acquired a New Asset? Look Out for These 3 CMC Data Challenges
With M&A ramping back up, CMC leaders need to be ready for new data integration challenges. Here are three to watch for.
Riding Out the RIFs: How to Layoff-Proof Your CMC Knowledge
Layoffs, downsizing, restructuring: For drug developers, the workforce hits just keep coming. For big pharma and smaller startups alike, it’s been a tumultuous couple of years in drug development.
Regulatory Goes Digital: Chapter 5 in Our Series on Drug Development Data
In the final chapter of our series, Yash dives into one of the biggest upcoming shifts in drug development’s data paradigm: moving to structured, cloud-based regulatory submissions.
Enabling Pre-commercial Product Lifecycle Management (PLM) for Pharma & Biotech
For drug developers, pre-commercial product lifecycle management (PLM) is quickly becoming essential for regulatory compliance and operational efficiency. Learn how digital CMC tools can enable it.
Getting Leaner, Going Digital: 4 Ways Drug Developers Are Adapting to a New Market
Drug developers are downsizing their way into a new era of efficiency. Here’s why they need digital infrastructure like QbDVision more than ever.
New Updates to the FDA’s PAI Process Put Drug Developers on Notice
With the new CPMG Objective 4, the FDA has officially put knowledge management and QRM on the menu for PAI audits. So what does that mean for drug development programs?
Six Trends That Will Define Digital Drug Development in 2024
New innovation, more challenges, and even bigger pressures: Here’s where digital drug development is headed next, from AI, to quality management, to nurturing digital culture, and beyond.
Tech Transfers 3X Faster: How QbDVision Made it Possible
A major regional pharma company was struggling to get multiple CMC workflows off the critical path and implement “Right-First-Time” development practices. QbDVision brought them the solution they needed to achieve their transformation goals.
Why Knowledge Management and QbD Principles Are Key to Drug Development’s New Supply Chain Era
New drug products are calling for more innovative raw materials than ever. See why registering them with QbD principles is the new way forward for CMC programs.
