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5 Keys to Managing Information Technology in an FDA Regulated Industry

An IT career in the Life Sciences industry requires knowledge of regulatory requirements as well as having stringent controls and processes in place to ensure GxP requirements are met or exceeded. Here are some important items to address when managing information technology in an FDA regulated industry:

5 Takeaways from Preparing to Comply with the GDPR as a CDMO

What is GDPR? As a US based, small company, an EU law took some time to hear about. But once we did, we knew we needed to work on being compliant. Here are some lessons learned:

The Advantages of a Cross-Functional Staff Model in Pharmaceutical Manufacturing

As a CMO, Singota has chosen a cross-functional staffing model, spanning the functions of sampling/dispensing, formulation, filling, and finishing. Cross-functional staffing entails cross-training so that each employee can make the most of the skills they bring to the company, while acquiring new skills and perspectives.

Characterizing Novel Microparticle-Encapsulated Drug Formulations

In the previous blog post, we addressed the challenge of successfully formulating such compounds for oral administration. However, once you have successfully encapsulated an API, the next task is to characterize that product and understand its release kinetics.

Initial Considerations When Formulating Microparticle-Encapsulated Drugs

In part 1 of a 2 part blog series, we will explore some of the critical factors to consider when beginning work with these types of formulations.

The Internal Audit Process: How Your CDMO Keeps Tabs on Its Service Quality

When a pharmaceutical company engages a Contract Development and Manufacturing Organization (CDMO) to provide services, the most fundamental assumption is that the CDMO adheres to Good Manufacturing Practices (GMP). What entitles the CDMO to make that promise? The short answer is, it conducts regular audits of its own staff and business processes.