COFEPRIS Drug Registration Process in Mexico
Many companies entering Mexico underestimate how detailed the pharmaceutical regulations in Mexico can be. Once the application reaches COFEPRIS, extra […]
Drugs vs Medicines: Understand The Key Differences
What we casually call medicine may technically contain one or more drugs. A drug can be used in different ways,
Expected Patent Expiry Drugs List: Top Drugs Losing Patent Protection By 2030
Many blockbuster drugs that have held a strong position in the market are now moving closer to patent expiry. As
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
New Drug Application Meaning & Approval Process
Drug companies cannot market a new medicine in the United States without FDA authorization. That authorization is requested through a
EU IVDR Regulatory Compliance Requirements for IVDs
EU IVDR compliance requirements have become more stringent, with stricter conformity assessment expectations and comprehensive post-market surveillance obligations. All of
CDSCO Medical Device Regulations & Registration Process In India
India’s medical device market is growing quickly and is now the fourth largest in Asia. The country is pushing to
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
From QSR to QMSR: FDA’s Quality Revolution For Medical Devices
The medical device’s domain marked one of its biggest evolutions by release of transition from Quality System Regulation (QSR) to