Compliance
PRODUCTS
-
Industry leading pharmacovigilance solutions from clinical development through post-approval.
-
RImanager centralizes regulatory and product data, integrates with production, and streamlines planning, tracking, and approvals to bring new drugs to market faster and reliably.
-
PHCbi brand's 8.4 cu.ft. (238 L) compact microbiological heated and cooled incubator is designed to helps ensure highly accurate, reproducible environments that mimic real-world conditions. It offers precise control of temperature, a low humidity setting, and lighting protocols - making it ideal for microbiology testing and research, food and cosmetic shelf life testing, municipal wastewater testing, plant cell culturing, and more. It is completely programmable, allowing for direct numeric input with memory of operation, start dates and hours, clock mode and timer.
-
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.
-
We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.
WHITE PAPERS AND CASE STUDIES
-
Advancing Compliance And Digital Strategy To Align With Pharma 4.0
AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.
-
Become A High-Performing Clinical Site: Tools For Hospitals, Clinics, And Academic Centers
This paper will give you the keys to set up a new clinical site, find the right model, pass the sponsors’ feasibility processes, acquire the right technologies, familiarize yourself with rules and regulations, and successfully mitigate risks.
-
Maximize Output From Full-Time Employees
Learn about project-based insourcing solutions designed to give clients laboratory services support with flexible timeframes, and eliminate worries about co-employment and other regulatory concerns.
-
Safety First In The Field!
Accidents happen. According to the Occupational Safety and Health Agency (OSHA), they usually happen because companies, or their employees violate safety standards in ten key areas.
-
Green Communication: A Polycom Commitment To The Planet Polycom high definition telepresence, video, and voice solutions are changing the way organizations communicate. And that's a good thing for our planet. Although we may be geographically distant from our fellow workers, customers, and partners, we no longer have to travel to be effective. Thanks to high definition...
-
Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan
A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.
-
Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines
As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.
-
How Sharp Packaging's Clinical Packaging Process Is 30% Faster
Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.
-
Comparative Analysis For Non-IND Sites
A cancer research organization that facilitates multi-national clinical trials was in the planning and coordination of a Phase III drug trial and wanted to expand the trial to include German sites. Conducted under an IND, the trial was going according to plan until German regulations changed.
-
Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records
Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.
-
White Paper: The 5 Pitfalls Of Implementing Project And Workflow Management Software The benefits of implementing an end-to-end project and workflow management system may seem like a panacea to executives and senior managers. Operational efficiencies and increased collaboration among employees may result, along with improved compliance and a comprehensive real-time view of operations for rapid executive decision making.
-
Expectations On The Pathway To GMP For Gene-Modified Cell Therapies
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
NEWS
-
Traliant Unveils New And Redesigned Workplace Violence Prevention Training To Strengthen Employee Safety And Compliance11/20/2025
Traliant, an innovator in online compliance training solutions, today announced the launch of its new and redesigned Workplace Violence Prevention courses.
-
New ServiceTrade Inspections Delivers Unprecedented Efficiency And Revenue Growth Opportunities For Commercial Fire Contractors6/16/2025
ServiceTrade, Inc., the industry-leading provider of field service management solutions that enable commercial service contractors to build stronger, more profitable businesses, today announced ServiceTrade InspectionsTM.
-
Paylocity Advances One Unified HCM And Finance Platform With Launch Of Integrated Spend Management Solution7/22/2025
Paylocity, a leading provider of cloud-based HR, payroll and spend management solutions, today announced the launch of Paylocity for Finance, a strategic expansion of its modern workforce platform into the Office of the CFO.
-
New Flomatic AIS & BABA Compliant 12' Flo-Flex 745SC Surge-Stopper For Municipal And Industrial Water Systems11/12/2025
Flomatic Valves is proud to announce the official release of its new AIS (American Iron and Steel) and BABA (Build America, Buy America) Compliant 12” Flo-Flex 745SC Surge-Stopper.
-
My Visit Revolutionizes Field Management With Accurate Visit Tracker And EVV Tools6/5/2025
In an increasingly mobile and compliance-driven world, My Visit introduces a transformative solution for businesses and service providers that need to track field activity, manage mobile teams, and meet regulatory standards.