Unlocking the Advantages of eCTD 4.0 Compliance
The long-awaited eCTD 4.0 standard is now available, though it is not yet mandatory. Life sciences companies can tap into the detail of the standard…
Life Sciences
Enhancing Local Affiliate Engagement to Drive Dynamic Global Regulatory Processes
Achieving regulatory excellence depends on a combination of optimisation processes, effective global systems, high data quality, and enhanced affiliate collaboration. However, transforming information management at…
Boosting In-flight Data Management to Improve Efficiency in Life Sciences Processes
Pharmaceutical companies are placing greater emphasis on consistent and unified data flow throughout their operations, creating a flow of broader data and insights between functions….
Ensuring End-to-end Quality and Safety through Third Party Supplier Management
With disruption to the traditional supply chain, managing quality and safety in today’s complex and ever-changing global Life Sciences market can be a challenge. In…
Data Quality Governance in Life Sciences: 5 Misconceptions to Overcome
Over time Life Sciences regulatory processes will become increasingly data focused, driven by cross-functional data connectivity requirements and the growing need for structured data submission…
From Global Industry Disruption to Data-driven Industry Innovation: What Next for Life Sciences Regulatory Operations?
As 2022 drew to a close, Amplexor asked some of its closest industry partners and regular event speakers for their views on the most pivotal…
A day in the life of…Sapphire Hutchinson, Quality Control Analyst at Broughton
What are your main responsibilities? As a Quality Control Analyst, my work usually involves using various methods of chromatography, such as high-performance liquid chromatography, gas…
How Technology Supports Medical Affairs Operational Excellence
Ways to leverage technology in medical affairs to achieve more as the role evolves Perhaps more so than any other part of a life science…
Growing Smart Capabilities for a Data-centric Future
Most life sciences Regulatory teams still think and work in terms of documents, paragraphs and sentences when putting together collateral for marketing authorisation and variations…
The Business of Biospecimen Procurement needs to be Revised
The journey of a biospecimen used for medical research begins with the donor and ends in a research laboratory. What happens between those two points…