Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

A 5-Step Guide To Achieving Your Biosimilar Milestones On Time
As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.
From Open Cleanrooms To Closed Systems – What Is Driving The Change?
Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.
How To Implement Three Cleaning Best Practices For Your Cleanroom
Learn about the three cleaning best practices that will make a difference in your cleanroom, the importance of each step, and how to implement these strategies.
Meeting Annex 1: A Proactive Approach To Regulatory Compliance
It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.

Advancement Of Upstream Bioprocess Intensification
7/1/2025

Explore how two companies unite to streamline upstream process intensification with integrative technology to boost efficiency, scalability, and innovation in biopharmaceutical manufacturing.
N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit
6/30/2025

Discover a company that tripled productivity and cut costs by optimizing its seed train process to achieve major gains without infrastructure expansion.
Establishing And Safeguarding Shelf Life In Combination Products
10/27/2025

Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure product function, safety, and label claims through the entire supply chain.
Drive Innovation With Validation 4.0
7/1/2025

Discover how Validation 4.0 can revolutionize your organization by boosting innovation, efficiency, and compliance with strategies that overcome challenges and stay ahead of evolving regulations.
Key Regulatory Considerations For The Next Wave Of Gene Therapies
2/21/2025

The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.

Software To Automate And Digitalize Data Recording Steps In QC Workflows

Explore the technicalities of the M-Trace™ Electronic Test Record Software, a solution that automizes and digitalizes all data recording steps during sterility testing and other quality control workflows.
V31 Print Inspection System: Print Quality And Barcodes

The V31 Print Inspection System ensures label quality, verifying barcodes and text, and automatically rejects faulty labels, enhancing compliance and efficiency in labeling processes.
Scientific Insights Lab Simplifying The Journey From Molecule To Market

Drug development programs should aid customers in the successful mitigation of technical and regulatory risks to ensure drug products move swiftly through the regulatory approval process and into commercialization. Get service and support to help pharmaceutical and biopharmaceutical manufacturers Simplify the Journey™ from molecule to market.
Sterility Testing For Cell Therapy Bioproduction Samples

This useful tool helps to ensure quality and safety in cell therapy products through the use of a probe-based quantitative PCR (qPCR) assay to detect bacterial and fungal species.
The Future Of Glass Packaging Is Here

Review the potential of Corning Valor® Glass to optimize the fill/finish process and reduce total cost of quality as well as overall manufacturing cost.