Hub Classifications

This page contains a list of all of our content classes and their subclasses.

All points in the lifecycle of environmentally controlled and monitored spaces, including acquisition, commissioning, validation, maintenance, and excursions.

Individual and group training of your stability program personnel including online resources, discussion groups and industry peer organizations to help ensure knowledge and practices are up to date with industry and regulations.

Utilizing resources from third parties to ensure continuity of your stability program. Working effectively and compliantly with service providers and ensuring their compliance with your program requirements.

All aspects of packaging of materials for stability studies including establishing requirements in protocols and testing needed to ensure effectiveness.

Research and activity required to ensure you have the resources, chamber space, materials, and disaster contingencies in place to complete a study. This planning is usually required before effective study design.

Includes all the things you do to ensure patient safety. This means compliance activities such as change control, writing procedures, preparing for, and hosting audits, data integrity and deviation (CAPA) documentation.

Ensuring positive interactions with regulatory agencies through compliance with their requirements, including their expectations for reports and submissions commiserate with the product life cycle, and studies representative of their climate zones.

Chain of custody of stability material, from initial acquisition to storage, pulls for testing and finally destruction and the transitions between each link in that chain.

The end result of the data analysis. Regulatory expectations, industry practice and helpful how-to articles and guidelines to establish or extend shelf-life.

The math and art of statistics used in skillful data analysis and reporting of that analysis in a manner that meets reviewers’ expectations and supports your specifications and proposed for assigned.

After all resources and tests have been established, we document our study design in a protocol to ensure the study is reproduceable and meets the requirements of the product life cycle in question and is completed cost effectively.

The computer systems that ensure compliance, efficiency, and continuity of your stability program. This includes your LIMS, monitoring systems, change control and other high visibility applications.

Covers the various types of tests, their specifications and laboratory analyses, including methods and equipment issues.