In the dynamic landscape of the pharmaceutical industry, the Medical...
Don’t Let the Launch Lull You: Common Compliance Pitfalls for a Small Biotech’s First Medical Information Portfolio
Congratulations, you’ve made it! After years of R&D, clinical trials,...
Optimizing Pharmacovigilance Quality Management Systems: Strategies for Upkeep and Multi-Market Compliance in 2025
Discover strategies to optimize and maintain a Pharmacovigilance QMS in...
FDA Remote Regulatory Assessments (RRAs): Key Takeaways
In June 2025, the FDA announced the availability of a...
Effective Conflict Resolution & Navigating Challenges in QA Teams and Audits
Quality Assurance (QA) teams play a critical role in ensuring...
Pharmaceutical Cost of Quality Analysis
The pharmaceutical industry is subject to stringent regulations that demand...
Blockchain In PV
The industry is looking at utilising available tools and technologies...
Impact Of Virtual Audits On GCP Compliance: A Comparative Analysis
The process of performing audits has undergone a significant transition...
MHRA Releases New Guidance on Post-Market Surveillance for Medical Devices
The new UK Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great...
AUDITING A PHARMACOVIGILANCE DATABASE – SOME CONSIDERATIONS
Auditing of safety databases can be a complex proposition for...
Quality: The Heartbeat of Progress in Life Sciences – by Madhavi Nadgouda
As the CEO of a small but dedicated quality assurance...
Being in a constant state of inspection readiness: what processes help you be ready? – by Joshua Marsh
Inspection readiness is the state of being always prepared for...
Inspection Readiness Across GxP: Ensuring Compliance and Quality in Life Sciences
Ensuring a state of perpetual inspection readiness is crucial for...
Big-Name Audit Failures: Are They Putting Patient Safety at Risk
In the pharmaceutical industry, meticulous audits are not just a...
First hand experience at the SQA 40th Annual Meeting & Quality College
I had the great pleasure of attending the SQA 40th...