INSIGHTS ON REGULATORY COMPLIANCE
-
Environmental Monitoring For Aseptic Filling
Explore regulatory interest in modern environmental monitoring for aseptic filling, the benefits of biofluorescent particle counters, and their role in enhancing drug product safety and quality.
-
Analytical Strategies For Impurity Control In Antibody-Drug Conjugates
Antibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.
-
Characterization And Impurity Profiling Of Combined Amylin And GLP-1 Analogs
GLP-1 receptor agonists are transforming diabetes and weight loss treatment. Discover how to enable precise impurity analysis and characterization of complex, fatty acid-modified peptide therapeutics.
-
Accelerating Method Development And Manufacturing Of GLP-1 Analogs
Explore a streamlined LC-UV/MS workflow that empowers labs to meet rising GLP-1 drug demand with faster, more informed decisions that enhance compliance and impurity detection efficiency.
-
Are You Aligned With FDA's Computer Software Assurance Methodology?3/19/2025
Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.
-
Navigating EU GMP Annex 1 Revisions In Drug Manufacturing11/27/2023
Explore changes introduced by the revised EU GMP Annex 1, key considerations to maintain compliance, and stark statistics that underscore the consequences of non-compliance in this evolving landscape.
-
What Is The Biggest Problem With Inspector Training And Qualification?8/25/2025
Discover how a truly blind system eliminates bias from the human inspection process, improving data accuracy and validation of automated inspection systems.
-
Rethinking Liquid Handling Automation10/1/2025
Labs today require more than precision—they need systems built for flexibility, reproducibility, and trust. Explore how automation is evolving to meet the real-world needs of modern scientific teams
-
2025 State Of Validation: Key Insights5/14/2025
Discover what’s driving change in validation in your industry in 2025 by exploring key Insights for a first look at this year’s top trends, challenges, and opportunities in validation.
REGULATORY COMPLIANCE SOLUTIONS
-
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.
-
Discover how a robust, high-throughput proteomics sampling workflow enables precise protein quantification for both targeted and discovery research through reproducible preparation and labelling techniques.
-
Our team of analytical experts provides experience, efficiency, and technical proficiency in the development/validation of analytical methodology and GMP testing support for your project.
-
The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.
-
Experience reliable, user-friendly buffer exchange and sample concentration with a system enhanced with precise pressure control, improved stirring, and durable components for effortless lab-scale filtration.