USP and FDA Propose Updates to Good Storage and Distribution Practices
Updates have been announced by FDA and for USP <1079>. In this blog we cover these changes. USP USP <1079> has a series of chapters on Good Storage and Distribution Practices. Chapter <1079> applies...
FDA Pathways to Medical Device Approval
Commercializing your medical device in the US market often requires submitting a marketing application to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA...
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...
Meet the Expert: Renata Pankiewicz
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...
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...
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,...
Meet the Expert: Jennifer Daudelin
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...
Project Management isn’t brain surgery, but why is it so hard?
Here is the scenario: you are the leader of a group and you have been given the responsibility of driving the completion of a new initiative, an early or late-stage drug or devices program, or a...
Meet the Expert: Elina Koli
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...
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....