A Helpful Guide To The Regulatory Submission Process
The regulatory submission process is an important, if complex, part of bringing a new product to market.
How to Build a Strong Vendor Management Audit Program
Vendor oversight is a regulatory requirement that comes with some tough challenges.
Quality Events In Life Sciences, Explained
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...
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...
21 CFR Part 11 Compliance Checklist
Meeting 21 CFR Part 11 requirements is a critical concern for teams managing electronic records and signatures in FDA-regulated environments.
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...
RIM Explained: Regulatory Information Management & Systems
Regulatory information management (RIM) is not just a compliance task to cross off your preclinical checklist.
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...
EU MDR vs. FDA Regulations: Key Differences
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...
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...
Quality Made Simple: Getting Started with QMS
Establishing a compliant quality foundation can be a struggle for many small to mid-sized organizations...where do you start? How do you manage rollout? How do you create processes that are...