Artificial Intelligence Impact on Global Pharma Regulatory Affairs
Artificial Intelligence (AI) has been making significant strides across various sectors, and the pharma industry is no exception. One area […]
COFEPRIS Regulation of Nitrosamines in Pharmaceuticals in Mexico
Nitrosamines have emerged as a significant concern in the pharmaceutical industry due to their potential carcinogenic effects. As impurities that
Quality System Regulations (QSR) under 21 CFR Part 820
The Quality System Regulations (QSR), outlined in 21 CFR Part 820, are critical guidelines established by the U.S. Food and
Regulations for Pharmaceutical Registration in Hong Kong
Pharmaceutical market in Hong Kong has reached a significant size, estimated to be around $2.3 billion. This figure highlights the
Pharmacovigilance of Biologics in the USA (US FDA)
Pharmacovigilance plays a vital role in ensuring the safety and efficacy of biologics, which are complex therapeutic agents derived from
US FDA Pharmacovigilance Requirements For Drugs in the USA
Pharmacovigilance is a cornerstone of drug regulation in the USA, playing a crucial role in ensuring the safety and efficacy
MHRA Pharmaceutical Regulations and Registration in the UK
In 2024, the Pharmaceuticals market in the United Kingdom is poised for significant growth, with projected revenue expected to reach
Pharmaceutical Regulations and Registration in Australia
The pharmaceutical market in Australia is projected to reach USD 9.78 billion by the end of the year 2023 with
Pharmacovigilance In Clinical Trials
Clinical trials are an integral part in the development of medical products. It is done to ensure that the product