Designing Pharma Manufacturing Facility: 10 Mistakes to Avoid
Planning and designing a pharma manufacturing facility means creating a controlled, compliant, and efficient environment. This environment ensures safe and high-quality medicines are consistently produced. It involves careful site selection, zoning of clean and...
Design Control for Medical Devices: Key Elements & Importance
Design control for medical devices is a structured regulatory-mandated process. It ensures medical devices are designed to be safe, effective, and meet user needs before they reach the market. It is required under FDA’s 21 CFR, ISO 13485:2016, and indirectly under EU...
How to Register on CDSCO SUGAM Portal? Step-by-step Guide
The CDSCO SUGAM portal is India’s official online platform for regulatory submissions to the Central Drugs Standard Control Organization (CDSCO). It allows manufacturers, importers, and researchers to apply for approvals related to drugs, medical devices, cosmetics,...