Technical Writing for the Pharma, Device and Biotech Industries

Technical writing for the IT industry is quite different from technical writing for the pharma, device and biotech industries. Technical writing for the pharma, device and biotech industries is a combination of skills and science. On the one hand, it requires extensive knowledge required from these vast and diverse, albeit related industries. On the other, […]

Regulatory Filing Requirements and Compliance Processes for medical devices in Japan

The market for medical devices in Japan is pretty huge. It ranks third in the world after the US and the EU. At just over $ 35 billion a year, which is characterized by an annual growth rate of 3-4 percent; it is far bigger than the markets in the neighborhood, such as China, Malaysia, […]

Psychiatric care is postcode lottery, say medical experts

There are not enough NHS psychiatrists in some parts of the UK and more should be recruited to improve care, says the Royal College of Psychiatrists. In Scotland, there are 10 consultant psychiatrists per 100,000 people – but only eight for the same number in England and Northern Ireland, and just six in Wales. London’s […]

Validation the complies with ICH guidelines

A clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures, and acceptance criteria in calibration limits is required from professionals in the field of statistical analysis. They also need to have a proper understanding of process and quality controls, as […]

Validation in accordance with ICH guidelines

Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need […]