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MDR Regulations – Impact on Medical Devices

Medical Device

The EU Medical Device Regulation (MDR), effective since May 26, 2021, has brought significant changes to the global medical device industry. Outlined below are seven major ways the MDR is influencing...

Pharma/Biotech – USA, Europe Regulatory News, April 2023 Vol. 1

Biopharma

USA FDA Releases Guidance on ISO Data Standards for Medicinal Products To advance alignment with global standards for medicinal product data exchange, the FDA has finalized guidance on implementing...

Biotech Regulatory News, EU Regulatory News, European Medicines Agency, Pharma Regulatory News, Regulatory News, US FDA, USA Regulatory News

FDA Authority Over Cosmetics

Cosmetics

Cosmetics consist of mixtures of chemical compounds derived from natural or synthetic sources. They serve a variety of purposes, including cleansing, protecting, and caring for the body or skin. Makeup...

Cosmetic Labeling, Cosmetic Registration, FDA Cosmetics Regulations, Laws and Regulations, Product Safety

Maximizing Success and Mitigating Risk: The Strategic Role of Pharma Regulatory Intelligence Database in the Pharmaceutical Industry

Biopharma

Regulatory intelligence refers to the process of gathering and analyzing information about the regulatory landscape, including laws, policies, and guidelines, that may affect a particular industry....

Drug Development, Mitigating Risk, Pharma Regulatory Intelligence, Regulatory Affairs, Regulatory Intelligence, Regulatory Intelligence Database

Medical Device Labelling Requirements

Medical Device

The safe operation of a medical device must never come down to guesswork or trial and error. Safe and effective operation of a medical device must never rely on guesswork. Clear, accurate, and compliant...

Code of Federal Regulations, EU MDR, General Device Labeling, In Vitro Diagnostic, Medical Device Labelling, Medical Device Regulation, Unique Device Identification, US FDA

Regulatory reporting software

Standards

Regulatory reporting software helps in collecting data from systems of companies and produces regulatory reports by industry regulations. A regulatory reporting system helps in managing and automating...

Artificial Intelligence, Case Safety Reports, clinical research, health authority documents, manufacturing, quality, R&D, Regulatory Reporting, Regulatory reporting software, regulatory reports, Safety reports