Meet the Expert
Quality & Compliance
March 14, 2024
Meet the Expert: Rodrigo Perez
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Quality & Compliance
GxP
February 29, 2024
Understanding GxP Compliance in Drug and Medical Device Development Lifecycle
In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is...
Quality & Compliance
FDA
February 19, 2024
Demystifying CAPA Management: Overcoming Challenges in the Fast-Paced World of GMP
This article has been updated since its original publication date. Navigating the complexities of Corrective Action / Preventive Action (CAPA) in the drug and medical device industries often poses a...
Quality & Compliance
GxP
December 12, 2023
Value of Intentional Bias in GxP Vendor Audits
Discovering intentional bias in GxP Vendor audits: weighing its advantages, drawbacks, and strategies for effective mitigation. While the prevailing view suggests that GxP auditors should not be...
Quality & Compliance
Program & Project Management
November 20, 2023
The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...
Quality & Compliance
Quality Assurance
October 27, 2023
How to Give Quality Assurance the Respect It Deserves During a Post-Merger Integration
A typical post-merger integration (PMI) between two companies is challenging, time-consuming, stressful, and resource intensive. Even the companies most experienced with integration find these...
Quality & Compliance
GxP
October 23, 2023
Recognizing the Value of Outsourcing GxP Audits
In today's highly regulated pharmaceutical, biotechnology, and healthcare industries, maintaining compliance with GxP Practices, and other regulatory requirements is paramount. Failure to meet these...
Quality & Compliance
Program & Project Management
October 10, 2023
How to Avoid Blind-Spots in Your Early-Stage Drug Development Program
Navigating the landscape of vital drug development? Discover the five crucial areas that could make or break your success. Early-stage drug development encompasses the initial phases of researching,...
Quality & Compliance
Medical Information
September 25, 2023
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...