Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

How To Solve Complex Pediatric Dosing Challenges Using Tailored Solutions
With a partner who understands the science, the regulations, and the real-world demands of dosing children, development can move faster, smarter, and with greater confidence
Navigating The FDA's Drug Supply Chain Security Act
Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.
The Impact Of Instrument Characteristics On The Method Migration Of A Challenging USP Assay
To evaluate the impact of different systems on the USP monograph for azithromycin organic impurities, the organic impurities monograph was tested across multiple chromatographic systems.
Validation In Transition: 2025's Top Trends, Tools, And Takeaways
Join top validation experts for a dynamic panel discussion on the 2025 State of Validation Report—uncovering key trends, challenges, and innovations shaping pharmaceutical validation practices today.

Five Practical Considerations To Move From Concept To Clinic
12/17/2025

Learn more about five key factors for advancing targeted in vivo LNP programs, from formulation and targeting strategies to bioanalytical readiness and scalability.
Automated Active Microbial Collection In Aseptic Filling Lines
9/21/2025

Learn how automated environmental monitoring strengthens contamination control strategies, reduces risk, and supports intervention planning in aseptic filling lines.
What Happens When You Refuse To Compromise On Sustainability?
8/8/2025

Discover how an empty building shell became a sustainable nanomedicine hub and achieved 47% energy savings and 88% fewer emissions, which sets new standards for innovation in the biologics industry.
Reduce Batch Failure Risk With An Innovative Platform
6/11/2025

Enhance reliability in cell therapy manufacturing with an innovative platform. Discover how the closed system and automation reduce operator errors through smart monitoring, pre-checks, alarms, and detailed batch reporting.
Managing Endotoxins - Detect, Prevent, Remove
9/8/2025

Explore the risks of endotoxin contamination in drug manufacturing and discover sustainable, animal-free detection methods to ensure pharmaceutical safety and regulatory compliance.

Facilitate Compliance With 21 CFR Part 11

Review data collection system, software, and controls that should be considered with each institution's policies and procedures to achieve compliance with 21 CFR Part 11.
MES Reimagined For Single-Use Bioprocessing

Digitize bioprocessing workflows, reduce errors, and streamline QA with an MES designed to support modern manufacturing across pilot and commercial-scale operations.
A First-Of-Its-Kind Advanced Qualification Dossier

This unique and comprehensive “On-Demand” dossier is designed to address the qualification requirements and provide all the information needed for your specific assembly in one location.
SpectraMax M Series Microplate Readers

Configurable readers with triple-mode cuvette ports, validation tools, and compliance software.

The SpectraMax® M Series Multi-Mode Microplate Readers measure UV and visible absorbance, fluorescence, luminescence, fluorescence polarization, TRF and HTRF.
High-Purity Analytical Solvents: Consistent Quality For Applicants

Minimize variability and improve detection confidence with high-purity analytical solvents. Discover how tightly controlled specifications support cleaner baselines and more reliable results.