Analytical testing of drug substances and drug products plays a crucial role in protecting patient health, ensuring the maintenance of product quality throughout a drug’s lifecycle. These days, analytical method development and validation is outsourced to Contract Development and Manufacturing Organizations (CDMOs) and Contract Testing Organizations (CTOs). Outsourcing analytical laboratory services can accelerate timelines, ensure regulatory compliance, and provide access to sophisticated instrumentation that may not be available in-house.

Despite its advantages, outsourcing is not risk-free. Miscommunications and low-quality results can all spell trouble, including delays, missed milestones, and potentially, project termination. This is particularly true for small pharma, biotech, or compounding pharmacies, where it can be a struggle to get the attention of a project manager to troubleshoot problems, receive a response to your email, and move your project to the top of the analytical laboratory’s “to-do” list. Read More >