Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

Streamline Microbial Testing With Next-Gen Membrane Filtration
Membrane filtration is essential for microbial testing, but outdated workflows can slow labs down. Discover how a redesigned system improves traceability, ergonomics, and efficiency.
Calcium Carbonate Vs Titanium Dioxide: Why Particle Engineering Matter
Discover how particle-engineered calcium carbonate offers a viable alternative to titanium dioxide in tablet coatings, achieving good opacity, process efficiency, and comparable tablet properties.
How AI-Enhanced CAPA Systems Actually Work
Learn how AI can accelerate root cause analysis, predict quality risks, and streamline CAPA without compromising compliance or overwhelming your team with practical strategies.
Developing Effective Procedures
Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

A Rheologist's Guide To Regulatory Confidence
10/1/2024

Explore key rheology concepts and terminology, and learn how to generate the required rheological profiles using high-performance instruments.
How Non-Destructive Headspace Analysis Advances CCI Testing
9/13/2025

Opting to use headspace analysis to assess container closure integrity (CCI) for your drug packaging ensures robust data and CCI assurance to protect your product and maintain regulatory compliance.
Conquering Challenges In Viral Vector Production
8/27/2025

Scaling gene therapy demands precision and actionable data. Discover how integrated technologies like ultracentrifugation and mass spectrometry enhance AAV yield, purity, and characterization.
The GxP Digital Maturity Model
8/8/2025

Explore how the GMP Digital Maturity Model guides life sciences companies through five stages to improve compliance, efficiency, and profitability with strategic digital adoption.
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.

Enhanced Opacity With Ideal Particle Properties

Titanium dioxide is extensively used in solid dosage forms as an opacifier and colorant. Due to regulatory developments and restrictions by authorities, formulators are increasingly interested in titanium dioxide-free solutions for both dietary supplements and medicinal products. Uniform colored and white coatings applied to tablets not only have an aesthetic function but also improve patient compliance.
Transform GMP Data Into Actionable Intelligence

Explore a system that delivers real-time, compliance-ready analytics, which empowers teams with self-service dashboards, embedded reporting, and actionable calibration and maintenance data.
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.
Partner With The Experts In Annex 1

Prepare for Annex 1 compliance with expert-led support in contamination control, featuring solutions that cover risk assessment, validation, and training to ensure cleanroom safety and compliance.
A Cloud-Based Quality And Compliance Solution

Empower smarter decisions by combining trusted Salesforce integration and AI-enhanced quality management to drive efficiency, scalability, and continuous improvement across your organization.