Types of Medical Device Approval Licenses Issued by CDSCO in India
The healthcare sector holds a crucial position in safeguarding the nation’s health, with an importance given to the safety, quality […]
Responsibilities of Indian Authorized Agent for Medical Devices Import
An Indian Authorized Agent is an intermediate between the foreign manufacturer and the regulatory authority. Any foreign manufacturer who intends
Pharma Regulatory Contract Staffing Services In Asian Countries
Pharmaceutical companies are innovative and generic drugs marketed in countries around the world. With limited market potential and varying products
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