ISO 9000:2015 & ISO 9001:2015
ISO 9000:2015 and ISO 9001:2015 are pivotal standards in quality management systems (QMS), setting the benchmark for excellence across…
ICH Q8 – Quality by Design
The ICH Q8 guideline focuses on pharmaceutical development. It aims to establish a systematic approach to designing, developing, and manufacturing pharmaceutical products. This guideline is…
Navigating the Regulatory Maze: How PSC Biotech Lights the Way
Regulatory affairs (RA) is a profession in the life science industry that involves checking whether a business is following…
Regulatory Strategy Development for Life Sciences: Best Practices
Regulatory Affairs and Winning Regulatory Strategy Regulatory strategy development is critical for life sciences companies seeking to bring new…
Benefit- Risk Assessment for Regulatory process
Benefit-risk assessment is critical to the regulatory review process for life science companies and healthcare products, including drugs, biologics,…
Navigating Regulatory Inspections: Top 5 Remediation Best Practices
Regulatory compliance is essential in all industries, but it is easier said than done. Regulatory agencies strictly monitor organizations…
