In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

Realize safe, scalable, and compliant cell therapies by building analytical strategies that exceed regulatory expectations.

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

Often, transferring an analytical method from R&D to quality control fails; success depends on determining where “the best” and “the most reliable” intersect. Analytical method transfer suffers from ...

This article discusses why it is important to apply risk analysis, QbD, and DoE in the development of analytical methods. About a decade ago, FDA and other regulatory agencies introduced a series of ...

Advancing analytical techniques is all well and good, but unless those advances in technology are accompanied by matching strides in technique management, the true potential of better methods may not ...

Each department, from production to clinical research, deals with three types of work: maintenance, routine, and project work. The work shares vary with the nature of the work, but all departments ...

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