This article explores how digital maturity in process design and parameter management can drive significant time and cost ...

The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

You have full access to this article via your institution. Figure 1: Density of actively recruiting clinical sites of biopharmaceutical clinical trials worldwide. Assessing the regional ...

Union Minister Anupriya Patel delivered the keynote at the 15th IMWP, stressing India's commitment to pharmaceutical standardisation. The meeting, bringing together international leaders, focused on ...

Union Minister of State for Health and Family Welfare Anupriya Patel delivered the keynote address at the 15th International Meeting of World Pharmacopoeias ...

India’s leadership in pharmacopoeial standard setting is commendable, said Dr. Roderico H. Ofrin, WHO Representative to India, on Wednesday. Ofrin also stressed the importance of regulatory ...

There will also be deliberations on emerging issues in impurity assessment (Q3) and the implications of ICH Q6 guidelines ... standard-setting and regulatory harmonisation. In a statement, the ...

Such growth makes China an increasingly important player in the global biopharmaceutical industry, offering potential market ...