21.0 Post marketing surveillance data (vigilance reporting): The dossier should conta ...

7.3.1 Design and development planning: The manufacturer shall establish documented pr ...

THE CENTRAL BUREAU OF NARCOTICS (CBN) In India is a law enforcement agency under th ...

The Central Drugs Standard Control Organization (CDSCO) in India oversees the approva ...

ACPL thus acts as a strategic partner for businesses seeking to comply with BIS regul ...

5.4 Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensur ...

The Food Safety and Standards Authority of India (FSSAI) plays a pivotal role in ensu ...

9.2 Reproducibility: This section should include reproducibility estimates and inform ...