Pharmaceutical Excipients Definition, Types & Regulatory Guidelines
The main component of a drug product is the active pharmaceutical ingredient (API) but a finished drug product contains ingredients […]
Q-Submission Meetings for Medical Devices with US FDA
Bringing a medical device to the US market involves more than just paperwork — the FDA often expects early discussions
What Is CDSCO SUGAM Portal & Its Registration Process
The word SUGAM means “easy to approach” in Sanskrit. Just like how it means it was developed by CDSCO to
US Agent Responsibilities for FDA Compliance & Market Success
Foreign manufacturers planning to sell drugs, devices, food, or cosmetics in the US must appoint a US Agent. The FDA
Computer System Validation (CSV) In Pharma
Computer systems are widely used in the pharmaceutical industry. With an increase in the use of computer systems in regulated
Pharmacovigilance System Master File (PSMF)
Pharmacovigilance (PV) is one of the most important parts of the drug product process. PV deals with the detection, assessment
COFEPRIS Reliance Pathway: Mexico Regulatory Update 2025
Modernization of the COFEPRIS Regulatory Framework: Introduction of a Reliance Pathway Diario Oficial de la Federación (DOF) published a new
SFDA Cosmetics Regulations in Saudi Arabia | Registration & Import Guidelines
Cosmetics are huge in Saudi Arabia right now, and the government is paying close attention. SFDA, which oversees beauty products,
IND Vs NDA In Pharmacy: Key Differences
Bringing a new drug to market in the U.S. isn’t a straight shot. Before a company can even think about