Clinical Research Solutions
Welcome to Part 2 of our blog series on "What You Need to Know About GxP Independent Compliance Audits." In Part 1, we discussed the importance of GxP audits, the different audit types, and why...
Clinical Research Solutions
In this post, we’re going to discuss the various types of GxP Compliance Audits, internal versus independent third-party audits. the role that independent auditors play in conducting compliance...
Clinical Research Solutions
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
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
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
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
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...
Clinical Research Solutions
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
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
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)...