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 ...

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 ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

Learn how to navigate the regulatory landscape utilizing current method development technologies for impurity control in late-phase API manufacturing. This webinar will cover the method development ...

Since the introduction of Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP OES) in 1974, and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) in 1980, these techniques have ...

As drug development becomes more complex, so do the demands for accurate, reproducible bioanalytical data to prove their safety and efficacy. Method validation ensures the reliability of ...

This classroom-based course provides strategies to develop and optimise methods for liquid chromatography and LC-MS along with knowledge of advanced techniques for analysing complex samples. This ...

In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...