Life sciences companies face some of the strictest regulatory environments in the world. From FDA and EMA oversight to global standards like ISO 13485 and GDPR, compliance requirements...

Bringing a medical device to the U.S. market is rarely simple. Teams face a maze of regulatory pathways, and for new teams working on their first development cycle, the 510(k) submission...

If you work in regulatory affairs, you know how complex submissions have become.One product might require dozens of sequences across multiple regions, each with unique formatting, timing,...

Regulatory deadlines never slow down. Submissions are getting more complex, reviewers expect faster turnaround, and teams are often managing content across spreadsheets, email chains, and...

Regulatory lifecycle management (RLM) transforms compliance from a reactive burden into a strategic advantage. Companies with effective RLM processes scale faster into new markets while...

In life sciences, it's easy to overlook correspondence. Between protocols, submissions, validation plans, and controlled documents, emails and message threads can feel like background...

SOP drift. Duplicate files. Missed periodic reviews. Failed audits. These are all symptoms of a document management process that isn't built for regulatory rigor.

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

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. 

Introduction to Regulations

Medical device manufacturers operating in both the European Union and the United States must comply with two distinct regulatory frameworks: the European Union...