Drug Master Files (DMFs) are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug's identity, strength, purity and quality. The DMF procedure exists all over the world, from highly regulated markets (HRMs) through nearly regulated markets (NRMs). The HRMs, such as the US, EU, Japan, Can...