In regulated industries like pharma and MedTech, a Quality Management System (QMS) needs to do a lot more than check off a compliance checklist.

Corrective and Preventive Action (CAPA) processes are essential for any life sciences organization aiming to maintain product quality and regulatory compliance.

Combination products represent some of the most innovative therapies in life sciences, but they're also some of the most complex to develop, manufacture, and bring to market.

In the pharmaceutical industry, documentation isn’t just paperwork. It's proof that your processes are compliant, your team followed protocol, and your product is safe.

The regulatory submission process is an important, if complex, part of bringing a  new product to market.

Vendor oversight is a regulatory requirement that comes with some tough challenges.

Quality events in life sciences aren’t just routine compliance tasks.

They’re pivotal moments, and when they're handled well, they can accelerate development and build trust. Handled...

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...

Meeting 21 CFR Part 11 requirements is a critical concern for teams managing electronic records and signatures in FDA-regulated environments.

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...

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...

Regulatory information management (RIM) is not just a compliance task to cross off your preclinical checklist.