Clinical Research Solutions
Revised Annex 1, EudraLex Volume 4: Deadline to Comply: August 2023
The deadline to comply with the revised EudraLex Volume 4, Annex 1 is August 25th, 2013. Only for a sole point (point 8.123: "product transfer/loading/unloading areas for lyophilizers“) a later...
Clinical Research Solutions
7 Critical Factors for Successful Selection of CDMO for Cell and Gene Therapy Manufacturing
Developing, optimising, and manufacturing Advanced Therapy Medicinal Products (ATMP's), such as Cell and Gene Therapy (CAGT) products is extremely complex. The choice of a reliable Contract...
Clinical Research Solutions
How to Select the “Right” CMO Partner
There are many ways in which you can evaluate a Contract Manufacturing Organization (CMO) to identify the best fit for your company’s needs. Every company knows, timing is critical to success. But...
Clinical Research Solutions
Prepare for Your Next Audit: A 5-Point GMP Checklist
Ensuring you have full control over your processes, facility, and quality management system (QMS), and ultimately your final product quality, is a demanding and important task. An inability to do so...
Quality & Compliance
6 Tips to Prepare Your Medical Cannabis Facility for Inspection
You may be considering building a new facility for growing, harvesting, and processing medical cannabis, or perhaps you have an existing facility and want to export to the European Union. What should...
Quality & Compliance
6 Tips for Evaluating Your CMO’s PAI Readiness
The submission of your drug application (NDA, ANDA, BLA, etc.) is an exciting accomplishment, and one of the first major milestones is a pre-approval inspection (PAI) of the manufacturing sites...
Quality & Compliance
Conducting a PAI Mock Inspection: How to Execute and Evaluate Your Findings
Did you miss our last blog on PAI Readiness? Catch up here to learn what a PAI is and how to prepare. Congratulations! You conducted a Mock Inspection in preparation for your upcoming Pre-Approval...
Clinical Research Solutions
8 Common QMS Mistakes to Avoid
Previously in part two of this three-part blog series, “Mitigating Compliance Risk with Your Quality Management System,” we discussed how a robust and risk-based Quality Management System (QMS)...
Quality & Compliance
How Data Integrity Supports a Smooth Transition to Pharma 4.0
The coming pharmaceutical industrial revolution, Pharma 4.0, is an implementation of new systems into the various manufacturing processes leading to an automated production. Introduction of these...
Clinical Research Solutions
Why the FDA Should Never Be Your First Inspection
You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products, and one of the best ways to accomplish that goal is by...