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Site Master File (SMF) and Drug Master File (DMF)

Site Master File (SMF) and Drug Master File (DMF) SITE MASTER FILE A site master file (SMF) is a succinct document that provides information...

Pharmaceuticals Regulatory Agency Reporting

Regulatory Agency Reporting Once a pharmaceutical product is introduced into commercial distribution, a number of changes or events can trig...

Enforcement Actions of pharmaceuticals

Enforcement Actions Pharmaceutical companies and the regulatory agencies that provide oversight for their activities share a responsibility ...

Pharmaceuticals Regulatory Inspections

Regulatory Inspections INSPECTION AUTHORITY The Food, Drug, and Cosmetic Act (FDCA) grants the United States Food and Drug Administration (F...

Mutual Recognition Agreements in Pharmaceuticals

MUTUAL RECOGNITION AGREEMENTS Mutual recognition agreements (MRA) are international agreements that specify the conditions under which the p...

Pharmaceuticals Regulations and Guidances

Pharmaceuticals Regulations and Guidances It is necessary to possess the ability to interpret regulations and guidelines as published or adm...