CDSCO Approved FDC List and Fixed-Dose Combination Updates in India
Searching for a single, complete list of approved fixed-dose combinations (FDCs) in India? There isn’t one. The Drugs Controller General […]
Types of Medical Devices & Regulatory Classification Across Major Markets
Put a tongue depressor next to a pacemaker and the gap is obvious. Both count as medical devices, yet they’re
QSR to QMSR: FDA Quality Management System Regulation for Medical Devices
For years, medical device manufacturers supplying the US market worked under FDA’s Quality System Regulation (QSR). That changed on February
ANVISA Cosmetic Regulations and Registration Process in Brazil
Brazil is one of the world’s largest beauty and personal care markets. ABIHPEC reports that the sector represents about 2%
MDSAP Certification: Audit Process, Countries and Requirements
Medical device manufacturers often have to meet quality-system requirements in more than one country. Under MDSAP, they can undergo a
FDA Q-Submission Program for Medical Devices: Types, Process & Timelines
Before committing to a medical device submission, many companies want to know where FDA stands. Is the testing plan adequate?
What Is a Marketing Authorization Holder (MAH)?
Getting permission to sell a medicine in the EU/EEA is just the beginning. The person or company named on that
PADER in Pharmacovigilance: Meaning, FDA Requirements & Submission Timelines
PADER is short for Periodic Adverse Drug Experience Report. It is one of the ways FDA receives periodic postmarketing safety
Certification of Suitability (CEP): Application Process & Sister CEP Submissions
A CEP stands for Certification of Suitability to the monographs of the European Pharmacopoeia. It is used for substances covered