Subhi Saadeh sits down with Georg Digel, founder of Elevate CAPA, to break down what should trigger CAPA, and how to investigate the right way using practical tools and better

In this episode, Subhi Saadeh sits down with Elaine (Yi Ling Tan), Creator and Principal Consultant at MedTech Chopsticks, to break down China medical device market access and regulatory compliance

In this episode of the ICH Q series, Subhi Saadeh covers ICH Q4, which focuses on pharmacopeial harmonization. He explains why ICH Q4 exists, the problem it was created to

In this episode of Let’s ComBinate: Drugs + Devices, host Subhi Saadeh breaks down ICH Q3, the family of guidelines that define how impurities are identified, evaluated, and controlled in

In this episode of Let’s Combinate, host Subhi Saadeh breaks down the ICH Q2 guideline with a practical focus on analytical procedure validation. The discussion covers key definitions, core validation

In this episode of Let’s Combinate: Drugs and Devices, host Subhi Saadeh breaks down the 2025 draft update to the ICH Q1 guideline and explains what has actually changed and

In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh continues the Combinating with ICH series by breaking down how the International Council for Harmonisation (ICH) guidelines are

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh kicks off a new series focused on the International Council for Harmonisation (ICH) and its impact on drug and

???? Stay ahead in combination products, pharma, and medical devices ???? https://www.letscombinate.com ????️ Listen to more expert discussions on regulations, drug delivery, and quality ???? https://www.letscombinate.com/ Get expert insights on

In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what’s changing in FDA pre-approval and pre-license inspections—and why the

In this short episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means. He compares batch vs. continuous, explains how a

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh addresses five significant quality issues in the combination product space. This episode provides practical insights and strategies for