Regulatory Series | Fundamental Guideline for GMP Standards: ICH Q7 Guideline
Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech® Quality lies at the heart of every pharmaceutical process. You…
How Poor Compliance Impacts Your Bottom Line
Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech® Life science companies need to comply with laws, regulations, and…
FDA Combination Products Q&A
Written By: Jorge Sugranes, Regional Director of Latin America, PSC Biotech Here are some Q&A regarding combination products (CP)…
Quality Assurance (QA), Quality Control (QC) and Industry 4.0
Written by: Shauna Clizbe, Business Development Manager The biomanufacturing industry is currently undergoing a revolution in how it develops…
What is Gap Analysis and how is it conducted?
What is Gap Analysis? Gap Analyses is the systematic, documented review of an organization’s current state to identify gaps…
