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 […]
US FDA Compliance
Gain practical knowledge on navigating FDA regulations, including registration processes, documentation, and quality compliance. Resources designed to support companies in maintaining adherence to US federal guidelines.
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
RFD & Pre-RFD Submissions For Combination Products In USA
The healthcare landscape is in a perpetual state of transformation, and as a consequence, there is a noticeable surge in
US FDA Regulation of Nitrosamines In USA
Nitrosamines are a class of compounds known for their potent carcinogenic effects. Their discovery in pharmaceuticals has sparked significant concern
Pharmacovigilance of Vaccines in the USA (US FDA)
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other
US FDA Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
The Modernization of Cosmetics Regulation Act (MoCRA), which was signed into law on December 29, 2022, is a significant milestone
Medical Device Registration in USA by US FDA
The responsibility for overseeing the regulations of medical device companies involved in the production, repackaging, relabeling, and medical device registration
510(k) Registration with US FDA – Medical Device Registration in USA
Medical devices regulatory compliance is paramount to ensure patient safety and effective product performance. The 510(k) registration process, overseen by
Biologics and Biosimilars Regulations, Registration Process in the USA (FDA)
The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD