Self-Inspection in Pharma Companies: What to Look For?
Self-inspection in pharma companies is a planned, systematic internal audit process aimed to evaluate processes, facilities, and systems. It is designed to ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal quality...
US FDA Premarket Approval: Your Comprehensive Guide
FDA has three types of regulatory pathways, namely 510(k), De Novo, PMA, for medical device approval. US FDA premarket approval (PMA) is the most rigorous and stringent regulatory pathway. High-risk devices (Class III devices that sustain life or pose significant...
How Can Mid-Project Design Changes Impact Regulatory Approval?
Mid-project design changes can significantly delay or derail regulatory approvals. This is because they alter the validated product definition, thereby requiring new risk assessments, verification/validation, and updates to technical documentation. Hence, they often...