Global Drug Approval Process: Key Steps & Tips to Expedite Approval
Drugs are marketed only after their approval by regulatory authority. Only safe, effective and medicines of quality are approved by […]
Digital Health In Regulatory Affairs
The old traditional methods of diagnosis, treatment and prevention have certain drawbacks such as late detection of non-symptomatic diseases, lesser
Pharmaceutical Regulation and Registration Process in Japan
Pharmaceuticals in Japan are regulated by the PMD Act, published by the PMDA and MHLW. These are the two main
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
Medical Devices Regulations in European Union (EU MDR)
EU MDR defines the conditions under which medical devices can be placed and maintained on the European market. Beyond certification,
Pharmaceutical Regulations in European Union
Many regulatory delays in European Union happen not because of non-compliance, but because requirements are misunderstood early on. Different approval
Artwork Proofreading & Quality Check for Top-50 European Biopharma Clients
Artixio is helping pharmaceutical companies with their artwork and label compliance through proofreading and quality check services using manual as
Biologics & Biosimilar Regulations in European Union (EU) (EMA)
In Europe, biologics and biosimilars are evaluated through a lens of scientific comparability and public health responsibility. For executives, this
Biologics and Biosimilar Regulation and Registration in Japan (PMDA)
With the exception of the United States, Japan’s biosimilar business, with a market value of $140 million, accounted for just