ANVISA Nutraceutical Dietary Supplements Regulations in Brazil
With the increasing health consciousness among the Brazilian population of 215 million, there has been increasing demand for nutraceuticals and […]
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
Global Regulation of Food Products
The recent rejection of food items, particularly spices, by the European Union due to the presence of carcinogenic ethylene oxide
What Is Company Core Data Sheet (CCDS)?
The label of a pharmaceutical product is of great importance and allows for its safe and effective use. Speaking of
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
Nano-Biotechnology: Tiny Innovations With Big Impact On Biologics
Nano-biotechnology is an interdisciplinary field that combines nanotechnology and biotechnology to manipulate and study biological systems at the nanoscale. The
COFEPRIS Pharmaceutical Regulations & Registration Process in Mexico
COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is the regulatory authority responsible for pharmaceutical regulations in Mexico. Any
Global Regulation of Infant Formulas
Infant formula plays a crucial role in providing essential nutrition to infants who cannot be breastfed, helping to support their