Quality & Compliance
Your Vendor Audit Program: On-site or Remote / Virtual?
It is quite common that a sponsor company will outsource services to external vendors, whether for additional expertise, remote locations, or simply due to lack of availability of resources within...
Clinical (IMP) Drug Supply…It’s Complicated
Things to consider and how to ease the process IMP Supply Management is a journey where GMP meets GCP and GDP. This journey includes finance, flow of products and documentation. How a company manages...
Clinical Research Solutions
From Idea to Market: The Five Stages of Product Development
The exact product development process for medical devices differs from region to region, with different regulatory expectations that need to be met in the EU, USA, UK and other regions. These precise...
7 Critical Factors for Successful Selection of CDMO for Cell and Gene Therapy Manufacturing
Developing, optimizing, 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...
Quality & Compliance
The 5 Phases of Project Management + Pro Tips for Success
Guilty as charged! I used to think a project manager’s (PM) sole job was to remind everyone about deadlines and set up status meetings. I learned firsthand while working at a medical device start-up,...
What is Product Lifecycle Management and Why is it Critical for Success?
Product Lifecycle Management (PLM) is the process of managing a product from conception through end of of life (EOL), and clearly includes conception (design and development) and commercialization....
Quality & Compliance
Roadmap for Successful IVDR Transition, Part II: Technical Documentation & Software
The compliance dates for the In Vitro Diagnostics Regulation (IVDR) are quickly approaching (May 2022). In this blog series, we discuss the final months before the IVDR date of application along with...
Quality & Compliance
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...
Quality & Compliance
Fundamentals of Data Integrity for ATMP Development
Advanced Therapy Medicinal Products (ATMPs), or Cell and Gene Therapies (CGT), have the incredible potential to cure devastating illnesses, such as cancer, on a more personalized level. But, due to...
Quality & Compliance
What to Expect From an FDA Inspection, Part 2
In this continuation from “Preparing for an FDA Inspection” I will discuss what I have witnessed as a typical outline of events for FDA inspections. Prior to setting foot at the facility, the FDA...
Quality & Compliance
United in Diversity: Six Tips for European Batch Release
Europe consists of 44 countries, and 21 supranational organizations and within the EU alone there are 24 official languages. So, how do you navigate the differences across Europe in the EU? And more...
Quality & Compliance
Deep Dive: FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring
In January 2020, FDA published a guidance document entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient...
Quality & Compliance
Preparing for an FDA Inspection, Part 1
The ultimate goal of the U.S. Food and Drug Administration is to protect the public welfare and protect consumers from unsafe products. Regulatory investigators are responsible for enforcing...
Quality & Compliance
What is Software Quality Assurance (SQA) and Do You Need it For Your Business?
If your only method of quality assurance is software testing, you're wasting valuable time and resources. Software Quality Assurance (SQA) is integrated into your software development life cycle to...
Quality & Compliance
Meet the Expert: Gary Hyde
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
Project Management and a Successful Reduction in Investigations Backlog: The Beauty and the Beast
Many of us have been faced with this beast that needs taming: a regulatory agency has conducted an inspection of your facility. Their observation is that the backlog of investigations at your site is...