INSIGHTS ON REGULATORY COMPLIANCE
-
The Role Of IV Bag Inspection In Drug Manufacturing
Advanced IV bag inspection technologies ensure patient safety and regulatory compliance in drug manufacturing. Learn more about automated leak detection and quality control innovations to optimize your business.
-
Why Compounding Pharma Manufacturers Should Evaluate BFS Systems
Discover how BFS technology offers compounding pharmacies and 503B facilities enhanced sterility, reduced errors, cost savings, and superior product integrity for aseptic pharmaceutical manufacturing.
-
ICH Q12 Implementation: Regulatory Intelligence And PACM Agility
Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.
-
How Robotic Isolator Technology Aligns To Annex 1 Principles
Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.
-
Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance7/28/2025
Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.
-
De-Risking The Transition From Vial To Drug-Device Combination Product7/25/2025
When transitioning from a vial to a combination product system, the best approach is to have a holistic de-risk strategy with an intentional focus on the patient, the plan, and the product.
-
Navigating Cleanroom Compliance For Safe Material Transfer7/23/2024
Watch to explore various aspects of environmental monitoring essential for the transfer of materials into controlled areas as well as recent advancements that can facilitate this task.
-
From Compliance To Process Control: Enabling Preventive Monitoring Through Smart CPV7/3/2025
Learn to leverage Continued Process Verification (CPV) and analytics for early detection of process drift, enabling preventive monitoring and enhancing overall process robustness.
-
Accelerate Biologics Product Release With Seamless Viral Testing6/23/2025
Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.
REGULATORY COMPLIANCE SOLUTIONS
-
Prepare for GMP audits with confidence through expert guidance and tailored coaching. Explore how this service helps you navigate the regulatory complexities of advanced aseptic filling systems.
-
Prepare for Annex 1 compliance with expert-led support in contamination control, featuring solutions that cover risk assessment, validation, and training to ensure cleanroom safety and compliance.
-
Filter integrity testing reaches a whole new level with the Palltronic Flowstar V featuring higher safety margins with a plug-and-play network integration.
-
A CDMO with the right team of experts can aid drug development, regulatory compliance, and clinical trial supply, accelerating timelines to first human dose clinical trials and the path to market.
-
Therapies are more complex, tailored, and varied than ever, and the associated amount of data is growing – which requires a new level of attention to detail.