Atlas Compliance Blog

In pharma, compliance is essential for your business. When the FDA conducts inspections, being unprepared is not only risky but also costly. The FDA conducts around 12,000 domestic inspections and 3,000 foreign inspections each year in more than 90 countries. Many of these inspections result in Form 483s and warning letters, often due to avoidable […]

Understand the key elements of GxP compliance to help ensure product safety, stay aligned with regulations, and avoid costly penalties in the life sciences sector.

Pharmaceutical regulatory compliance is a critical and growing part of the industry. The U.S. pharmaceutical regulatory affairs market is expected to reach over $2.4 billion by 2030, growing steadily at nearly 8% annually from 2024.  This growth highlights how important it is for pharmaceutical companies to manage compliance, both to meet strict safety standards and […]

tl;dr: FDA inspections are not just regulatory checkpoints but critical evaluations of your quality systems, documentation, and risk posture. Whether it’s a routine inspection, a for-cause audit, or a pre-approval inspection, here are 100 essential elements that FDA inspectors often review in the FDA compliance checklist. 1–20: Data Integrity & Documentation (21 CFR Part 11 […]

In the life sciences industry, product quality and regulatory compliance are non-negotiable. When deviations occur, organizations must act quickly and effectively, not just to fix the issue but to ensure it never happens again. This is where CAPA comes into play. In this definitive 2025 guide, we’ll break down everything you need to know about […]

In 2025, the Center for Biologics Evaluation and Research (CBER) approved a series of groundbreaking biological products and devices, each contributing to advancements in healthcare and patient safety. Below is an overview of notable approvals and regulatory developments during this period. Biological License Application (BLA) Approvals Automated C3d Plate (Anti-Human Globulin, Murine Monoclonal) Noteworthy BLA […]

The medical device industry operates under strict regulatory oversight to ensure product safety and effectiveness. The U.S. Food and Drug Administration (FDA) is pivotal in establishing and enforcing compliance standards. In 2023 alone, the FDA issued over 1,200 warning letters related to medical device compliance, highlighting the increasing scrutiny of manufacturers. Staying informed about these […]

In today’s highly regulated pharmaceutical landscape, staying ahead of compliance issues is critical. Regulatory inspections and enforcement actions can significantly impact operations, product approvals, and market confidence. That’s where Atlas comes in—an advanced FDA inspection intelligence platform that provides real-time notifications on inspections and regulatory events, ensuring manufacturers are always informed and prepared. Why do […]

For pharmaceutical, biotech, and medical device companies, FDA inspections are a critical part of regulatory compliance. One of the most valuable ways to prepare for an inspection is by understanding the background and focus areas of the specific FDA investigator assigned to your facility. But is it possible to search for specific FDA investigators and […]

For pharmaceutical, biotech, and medical device companies, FDA inspections are critical to ensuring product quality, regulatory compliance, and market access. However, preparing for an FDA inspection can be daunting, requiring companies to navigate complex regulations, analyze past inspection trends, and proactively address potential compliance gaps. This is where Atlas, an advanced FDA inspection intelligence platform, […]