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...
Clinical Research Solutions
12 Critical Questions and Answers for a Successful Tech Transfer Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time,...
Clinical Research Solutions
There has been a lot of discussion recently concerning process validation and technology transfer, including utilizing virtual technology transfers to quickly move products through the development...
Clinical Research Solutions
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...
Clinical Research Solutions
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)...
Clinical Research Solutions
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...