Newsletter | June 5, 2025

06.05.25 -- FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating

SPONSOR

Webinar: What Your Environmental Monitoring Isn’t Telling You

Discover the hidden risks your environmental monitoring (EM) might be missing in this Contec webinar. Learn how stable EM trends can create a false sense of security, overlooking issues like environmental residues, poor housekeeping, and inadequate operator training. Gain practical strategies to enhance contamination control, supported by real-world examples and expert insights, and receive checklists to improve cleanroom management immediately.

INDUSTRY INSIGHTS

Die Bore Cracking: How To Achieve Reliable Tablet Production

Die bore cracking is a significant issue in tablet manufacturing, affecting the quality of the tablets and potentially damaging the tablet press. Explore how to analyze for and prevent this damage.

4 Steps To Implementing Predictive Quality Analytics In Manufacturing

Stay competitive in Industry 4.0 by reading how predictive quality analytics, powered by AI and ML, transform manufacturing by predicting outcomes, optimizing processes, and minimizing disruptions.

Developing Assays For Insulin Analogs And Other Large Peptides

Learn how a physicochemical-based approach can help to accelerate the development of bioanalytical assays for insulin analogs, avoiding delays and increasing efficiency in clinical trial processes.

Overcome Common Pre-Filled Syringe Challenges Through Partnership

The pre-filled syringe space is one of the fastest-growing pharma sectors, offering greater patient safety. But pre-filled doesn’t translate to easily filled; there are particular obstacles to overcome.

Optimizing Highly Potent API Drug Development And Manufacturing

Through expert insights and real-world case studies, this resource provides valuable perspectives on optimizing HPAPI workflows, ensuring compliance, and leveraging process advancements.

7 Reasons To Embrace AI-Enabled Digital Validation

Are you overwhelmed by paperwork during validation projects? Discover how AI-enabled validation can streamline operations, strengthen compliance, and keep you ahead in fast-paced industries.

Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Development

Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.

Small Is Powerful And Sustained

Advances in sustained-release drug delivery could improve efficiency and consistency in drug release, manifesting real-life advantages for patients in the form of enhanced accessibility and compliance.

The Role Of Training Devices And Education In Self-Injection Therapies

Review the evolution of injection devices and prefilled syringes, the benefits of training devices combined with patient education, and an empirical look at patient training.

A Modern Environmental Monitoring System That Grows With Its Tasks

Modern environmental monitoring systems are vital for pharmaceutical manufacturing. Examine the benefits of a tool for data collection, analysis, and processing that ensures compliance and adaptability.

Innovative ASD Technology Improves Abandoned Cancer Medication

Gain insight into how one solid dispersion technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.

New Vs. Used Processing Equipment: A Cost Comparison

For pharmaceutical and chemical manufacturers, balancing budgets with operational needs is crucial. Uncover how sourcing used equipment offers significant cost advantages over new.

A Paperless Lab Simplifies Full Sample Lifecycle Data Management

See how implementing an electronic lab solution helped Crown Bioscience realize electronic experimental records that optimize business processes and help them to be more standardized.

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Webinar: Unlocking Data Integrity: Proven Strategies for GxP Compliance and Inspection Readiness

Join this IDBS webinar to explore practical strategies for achieving data integrity and GxP compliance. Learn how to build a robust data integrity framework, interpret regulatory expectations, and apply real-world insights to strengthen inspection readiness. Don’t miss this chance to enhance compliance, reduce risk, and protect product quality and patient safety—register now!

FEATURED EDITORIAL

FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating

Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

SOLUTIONS

Highly Modular, Adaptive Digital Transformation Platform

Developing Pediatric Formulations

Capacity Update April 2025: Small Molecule

Cleanroom Classification Zone Creation For ISO 14644, Annex 1

AI-Enabled Route Scouting Service

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