IVDR & Companion Diagnostics: Regulations and Market Strategy
The integration of diagnostics and therapeutics is rapidly reshapi...
US FDA Requirements for Design Verification and Design Validation Activities
What is Design Verification?
Design Verification is a critical ste...
Software as Medical Device: Agile Alignment with GAMP5 Validation
The GAMP 5 framework/five-phase approach (Refer Fig) provides a st...
Regulatory CMC Changes for Pharmaceutical Products
All the biopharmaceutical companies must follow respective nation’...
