If Congress starts reviewing licensing deals, diligence gets a documentation problem
Historically, national security reviews were not a topic of conversation in biotech licensing deals. Things are changing.
When an AI Agent Runs the Analysis, Who Signs the Record?
When an AI agent runs the analysis, who signs the record?
Research and development organizations in 2026 find themselves in a unique position. AI agents are increasingly implemented into...
Pharmaceutical Document Management: A Modern Guide For Life Sciences
Last Updated: September 2026
What’s the difference between a QMS and a document management system for pharma teams?
A document management system (DMS) is the infrastructure that creates,...
Webinar: Data Management for Diligence, from Discovery to Development
Data rooms are central in biotech: they not only underpin key events like fundraising, asset licensing, and M&A, but also actively inform R&D roadmap decisions. BD partnerships, pharma...
The Role of Virtual Data Rooms in Drug & Device Development
In biotech, the term "virtual data room" often conjures images of fundraising diligence: a static folder of key documents used to satisfy investors or legal teams during a transaction. But...
All About 21 CFR Part 11 Compliance
What is 21 CFR Part 11?
21 CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) that sets the criteria for electronic records and electronic signatures...
The Future of eQMS: How Automation is Changing Compliance and Quality
As regulatory requirements become increasingly stringent in the pharmaceutical and medical device industries, companies must adopt efficient, scalable, and compliant solutions to manage...
What's Good in QC? Understanding Quality Control and Compliance Standards: GQC, GMP, GLP, GCP, and GDP
Maintaining high standards of quality and safety in life sciences industries is essential. Several globally recognized quality management systems have been established to ensure...
Toban Zolman joins Steve Gens to discuss Kivo's rapid growth
In this episode of the Gens & Associates Podcast, Kivo CEO Toban Zolman joins managing partner Steve Gens to discuss Kivo's success with smaller stage life science companies, Kivo's process...
Drug Development Trends for 2025 and Beyond
As we look ahead to 2025, there’s no doubt that we’re at a transformative moment in the life sciences industry. The pace of change is accelerating, driven by groundbreaking advancements in...