quality compliance

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...

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Clinical Research Solutions

12 Critical Questions and Answers for a Successful Tech Transfer

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

Is Your Technical Transfer Process Aligned with Process Validation Requirements?

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

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...

Clinical Research Solutions

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...

Clinical Research Solutions

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)...

Clinical Research Solutions

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...

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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...

Regulatory Sciences

Outsourcing Functions Doesn't Mean You've Outsourced Compliance Obligations

Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...

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