INSIGHTS ON REGULATORY COMPLIANCE
-
![West-BIO 1 - 88_NovaPureSyringes_0922]( "A Pathway For Regulatory Success For Devices In Combination Products")
A Pathway For Regulatory Success For Devices In Combination ProductsReady to improve your submission success rate? Define clear submission goals, ensure cross-functional collaboration, and proactively manage evolving regulations to achieve a successful path to market.
-
![GettyImages-186823098 cleanroom]( "Visualizing Airflow With Smoke Studies For Aseptic Manufacturing Excellence")
Visualizing Airflow With Smoke Studies For Aseptic Manufacturing ExcellenceJHS uses smoke studies to visualize airflow in cleanrooms, ensuring aseptic conditions and regulatory compliance for sterile pharmaceutical production, especially on new aseptic filling lines.
-
![GettyImages-1443975905 lab, analytics, technology]( "Human Performance In Pharma: Strengthening The Biotech Workforce")
Human Performance In Pharma: Strengthening The Biotech WorkforceTransforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.
-
![GettyImages-2183428951-biomanufacturing]( "Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities")
Biomanufacturing Readiness: A Validation Model For Multiproduct FacilitiesOptimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.
-
Indian Biosimilar Companies Are Poised To Succeed In The Global Market3/31/2025
For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.
-
The Impact Of The FDA's New CSA Draft Guideline2/24/2025
Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.
-
Leveraging A Modern HPLC System For Peptide Drug Substances Analysis8/22/2024
This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.
-
Combination Products: Navigating Regulatory Strategy, Design Verification5/19/2025
Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.
-
Streamline Drug Development With A Lab Informatics Platform8/13/2025
Learn how a tiered approach to ADME-Tox studies can help researchers navigate early-stage preclinical research and mitigate the risk of costly failures in drug development.
REGULATORY COMPLIANCE SOLUTIONS
-
![Versa Flex and Versa Flex GP Checkweigher]( "Versa Flex and Versa Flex GP Checkweigher")
The Thermo Scientific™ Versa Flex and Versa Flex GP checkweighers are designed to improve accuracy and reliability, decreasing maintenance and product giveaway. Our global manufacturing and service teams enable a high level of solutions and service support wherever you do business.
-
![Pharmaceutical Container Closure Integrity Testing For IV Bags]( "Pharmaceutical Container Closure Integrity Testing For IV Bags")
The Food and Drug Administration (FDA), United States Pharmacopeia (USP) and EMA Annex 1 issue strict guidelines for testing the integrity of IV bags and containers closed by fusion. IV bag manufacturers are one among many sterile product manufacturers that must meet these test requirements for container closure integrity.
-
![White Tablets-GettyImages-172969989]( "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.
-
![Scientist working in laboratory-GettyImages-2215842283]( "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.
-
![GettyImages-499923228 (1) technology]( "Adopting Enabling Informatics Technologies To Drive Digital Transformation And Data Integrity")
Learn how to transform your contract organization into a completely paperless, connected lab with our informatics solutions, which deliver robust, proven results and reduce regulatory risk.
