Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

How A CDMO Gained 40%+ Efficiency By Generating Automated APQRs
Discover how a CDMO's mounting challenges with manual product quality review (PQR) processes were resolved through the implementation of a next-generation cloud-based solution.
Overcoming Excipient Risks And Challenges For Parenteral Formulations
Excipients are essential to parenteral formulations, which help protect APIs, enhance stability, and ensure safety. Learn how strategic excipient selection can optimize drug performance and patient outcomes.
Solving The Silicone Challenge In Pre-Fillable Syringes
Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.
Integrating Phase-Appropriate Quality Standards
Incorporating phase-specific quality standards ensures GMP compliance. Collaborating with an experienced CDMO addresses late-stage quality needs and efficiently manages development timelines.

5 Drug Manufacturing Trends To Look For In 2025
1/6/2025

The life sciences industry faces big changes in 2025. Companies must adapt to new regulations, AI, and shifting manufacturing landscapes to stay competitive and drive innovation.
Cell Therapy Process Development Made Easy
3/27/2024

Explore how Fast Trak™ process development services offered by Cytiva can guide you through achieving GMP compliance in your cell therapy manufacturing process.
Biotech Firm Streamlines Maintenance, Calibration & Validation With RAM
8/8/2025

Explore how a U.S. biotech company uses RAM to centralize maintenance, calibration, and validation to improve compliance, efficiency, and visibility across multiple facilities.
Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation
9/17/2025

Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.
Ensuring Integrity: Testing Viscous Biologics In Pre-Filled Syringes
12/18/2025

Viscous biologics in pre-filled syringes demand precise integrity testing. Discover how advanced HVLD technology detects micro-defects and ensures sterility, meeting stringent USP <1207> standards.

Manufacture High-Quality Products With Streamlined Compliance

Manufacture high-quality products with streamlined compliance.
Corrective Action Preventive Action (CAPA) Software For Life Sciences

Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.
The Key To Better Visual Inspection Practices

Bridge regulatory gaps in visual inspection and improve product quality by managing defects throughout the product lifecycle. Get a better understanding of how a centralized data repository can help.
Highly Potent And Complex API Contract Manufacturing

Equipped with a diverse array of scales, our seasoned experts possess the finesse and acumen necessary to tackle even the most intricate and potent API projects.
Software For Trusted And Efficient Data Recording

Discover your digital QC companion for sterility testing and other regulated processes. Ensure full traceability and regulatory compliance with contemporaneous, automatic, and complete recording of QC testing data.