Guest Columns

31. 4 Key Considerations For Onshoring Or Nearshoring Of Drug Production 6/28/2023

    Is reshoring or nearshoring right for your organization? It's important to undertake rigorous internal assessments to arrive at a decision. Here are four key considerations.

32. ICH Q12 Post-Approval Change Management Protocol 6/27/2023

    The ICH Q12 guideline includes information about the post-approval change management protocol, which aims to simplify the process of registering site changes under certain criteria through an emphasis on gaining accelerated up-front feedback from the regulator before compiling submissions. Following this protocol reduces the approval cycle by up to six months.

33. Agile Software Development In Bio/Pharma & Medical Devices, Part 1 6/27/2023

    Under the FDA and other regulatory bodies, the bio/pharma and medical device industries have been using computer software/systems validation testing methodologies to validate software within the GxP environment. Let's dive into the use of Agile methodology in the planning phase of a software development plan.

34. The Digital Future Of CMC Regulatory Affairs 6/23/2023

    This article discusses recent initiatives from the FDA, such as KASA, PQ/CMC, and the ICH SPQS. Let's look at how they could be the early birds of the paradigm shift from electronic CTDs to digital CTDs. The article also addresses what steps the industry should be taking in parallel with the authorities in preparation for this (very near) digital future.

35. Navigating Regulatory Guidelines For Effective Tech Transfer 6/22/2023

    The authors discusses important aspects of tech transfer (the project management plan, gap analysis, risk assessment, and more) and share the notable FDA and WHO guidelines related to each area.

36. An Agile Approach To Regulatory Information Management System Transformation 6/20/2023

    Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically. 

37. Lost CMC Data In An ALCOA+ World 6/19/2023

    As technologies advance, the drug/therapy products we make are becoming more complex, and so are their data fingerprints. This article takes a hard look at the way we currently capture and manage chemistry, manufacturing, and controls (CMC) development and manufacturing operations data, and sheds light on how the document-centric mindset of ALCOA+ is not suitable to support the transition to digital CMC and FAIR data management.

38. FDA Seeks Input On AI Adoption In Drug Development And Manufacture 6/13/2023

    The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.

39. A Practical Look At Data Governance In The Life Sciences 6/13/2023

    Without solid data governance, there is an increased risk of data discrepancies, misinterpretation, or even loss, which can hamper the development process. But what exactly is data governance? This expert shares a handy list of key considerations and strategies for moving forward.

40. 3 Action Items For The US Bio/Pharma Industry To Mitigate Supply Vulnerabilities 6/12/2023

    The United States’ reliance on foreign manufacturers of API has been a known fact for several years. We can mitigate our supply vulnerabilities, but bio/pharma companies and the FDA both have roles to fill in this need.