Newsletter | July 8, 2024

07.08.24 -- Integrating Risk Management With The Design Control Process

FEATURED EDITORIAL

Long Live Design Controls, Part II: A Systems Engineering Perspective In The QMSR Paradigm

The waterfall model and the V-model are commonly employed in medical device development. In our new era of the Quality Management System Regulation (QMSR), risk management can be integrated with the design control process.

INDUSTRY INSIGHTS

Using Advanced Technologies To Formulate Complex Molecules

In this survey, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them.

Customized Release Through Dispersed Dosage Formats

Typically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy.

AI: The New Partner In Drug Delivery Device Development

Involving users in the development process and staying informed about regulatory policies can help ensure AI-powered devices meet the needs of patients and healthcare professionals.

Ensure Speed And Success With Your Drug Delivery Project

Hear from experienced professionals in the drug delivery space on how to ensure success and speed-to-market by establishing a firm foundation when working with a CMO.

Characterizing The E&L Profile Of Stoppers For Drug Stability

The significance of E&L testing lies in its ability to identify potential risks associated with the use of containers and packaging materials in the pharmaceutical industry.

SOLUTIONS

Drug Product Fill/Finish And Formulation Solutions

Get Your Biologic To Clinic And Market Faster

Improve The Bioavailability Of Poorly Soluble Drugs