Tag: pharma

In this blog post, we describe the first step of a process for qualifying AWS services for use as part of GxP workloads, sometimes referred to in the industry as “whitelisting” services. AWS customers with GxP compliance requirements might want to control access to the AWS services their developers use. During the supplier assessment of […]

September 8, 2021: Amazon Elasticsearch Service has been renamed to Amazon OpenSearch Service. See details. Life Science companies are witnessing substantial growth in number of Adverse Events (AE) being reported for their products. This may be due to the increase in data volumes coming from journals, articles, social media, and non-standardized data sources. Evolving regulations […]

Introduction Bringing a new drug to market is a slow and laborious process. According to Tufts Centre for the Study of Drug Development, it takes on average between 7 to 10 years and costs more than $2.5 billion to bring a new drug to market. (1) More than half of this time and capital is […]

Good practice (GxP) guidelines were established by the Food and Drug Administration (FDA) and aim to ensure organizations working in life sciences develop, manufacture, and distribute products that are safe, meet quality guidelines, and are fit for use. GxP compliance has been a part of the life sciences industry for many years and heavily influences […]

Technology is changing how we practice medicine. Sensors and wearables are getting smaller and cheaper, and algorithms are becoming powerful enough to predict medical outcomes. Yet despite rapid advances, healthcare lags behind other industries in truly putting these technologies to use. A major barrier to entry is the cross-disciplinary approach required to create such tools, […]

Moderna is advancing messenger RNA (mRNA) science to create a new class of mRNA medicines designed to direct the patient’s own cells to produce proteins that have a therapeutic or preventive benefit. Developing therapeutics and vaccines for a variety of diseases challenges process development and operations to establish agile and flexible manufacturing, capable of executing […]