Annual Submissions for US in regulatory processes
Annual submissions are critical in regulatorysubmission processes to maintain a product’s quality, safety, and efficacy over its duration in…
Difference Between CTD and eCTD Submission Formats
What is an eCTD submission? The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common…
Fulfilling Requests During an Inspection
In this blog article series on regulatory affairs inspections, we discussed the importance of making a good impression when the inspector…
Preparing for an inspection: Building an Inspection Team
Site inspections regularly check and verify your organization’s regulatory compliance, safety standards, and more. The FDA, EHS, and the…
