Quality & Compliance
Staying GMP Compliant: A Consultant's Guide to Compliance Bliss
Hello, dear readers and fellow compliance enthusiasts! Welcome to our journey through the labyrinth of Good Manufacturing Practices (GMP) compliance. As a consulting company that provides audit...
Quality & Compliance
Ensuring Quality in Clinical-Phase Drug Manufacturing: A Comprehensive Guide
Importance of Quality Assurance in Clinical-Phase Drug Manufacturing Quality Assurance (QA) is a critical function in the pharmaceutical industry, ensuring that every aspect of drug manufacturing...
Quality & Compliance
5 Key Challenges in the Development of Gene Therapies
Over three decades of gene therapy (GT) clinical trials have yielded many innovative and promising treatments for pernicious genetic disorders but industry has shown slow development and dashed...
Quality & Compliance
A Guide to Solving Complex Life Sciences Challenges
Life sciences organizations are consistently inundated with decisions and challenges of varying scale. These can occur anywhere during the life sciences value chain, under any treatment modality...
Quality & Compliance
How to Decentralize Cell and Gene Therapy Treatments
The Challenge: CAGT Treatments Require Time and Lack Availability Persons diagnosed with life threatening diseases which are now treatable with cell and gene therapies (CAGT) often needed to wait for...
Maximizing Cost Efficiency: The Financial Advantages of Outsourcing Vendor Audits
In today's dynamic business landscape, organizations in the drug, biologics, and medical device industries face the dual challenge of delivering quality products while managing tighter budgets and...
FDA Publishes Guidance for CAR T Products
In January 2024, the FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products issued a guidance document- Considerations for the Development of Chimeric Antigen Receptor...
Quality & Compliance
The Importance of EU/UK QP Audits
In the highly regulated pharmaceutical industry, ensuring the safety, quality, and efficacy of medicinal products is paramount. One crucial aspect of this assurance lies in the oversight provided by...
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...
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...
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...
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...
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...
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...
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...
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,...