Compliance

PRODUCTS

  • Enabling you to design vaccines without reliance on animal sources with our fermentation-produced squalene.

  • 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.

  • Over-encapsulation is a popular, cost-effective technique that involves the blinding of a solid dosage form into a capsule shell in order to eliminate bias from comparative clinical trials, while maintaining study integrity and efficacy. If the blinding of the material is not adequately done, clinical trial participants may be able to tell the difference between the real drug and the placebo, resulting in a biased trial and a loss on your investment.

  • Purpose-built with users at the center to make it easier and more efficient to get quality patient outcomes data for submissions and approvals.

    Collecting quality data on patient outcomes is often one of the most important parts of a clinical trial. It is also challenging, and many eCOA solutions make it feel even more difficult with complicated processes, lack of questionnaire reusability, slow set up, and difficult to use tech.

  • For more than 20 years, Eurofins PSS Insourcing Solutions® has partnered with biotech and pharmaceutical companies to successfully validate and open new or remodeled facilities, meeting regulatory requirements. With a proven track record across numerous facility projects, our flexible, client-focused model ensures seamless integration with internal teams and third-party vendors, delivering high satisfaction and long-term partnerships.

WHITE PAPERS AND CASE STUDIES

  • Delivering Apheresis Treatment From The USA To The UK Within 24 Hours

    The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.

  • 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.

  • 24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments

    Get an overview of a successful re-route of six critical shipments to the UK and Spain from Amsterdam used to deliver CAR-T drug products to treat non-Hodgkin’s lymphoma cancer patients.

  • Pharma Manufacturing: Top 10 Pitfalls To Avoid

    Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?

  • Why Compliance-Driven CDMOs Win Sponsor Contracts

    Learn how digital maturity and compliance excellence are reshaping CDMO competitiveness, as well as strategies that strengthen performance and accelerate tech transfers.

  • Supporting the Pharmaceutical Industry with 21 CFR Part 11 Compliance Readiness The purpose of this document is to describe how PANalytical systems support system owners meeting the requirements of the 21 CFR Part 11 regulations issued by the United States’ FDA. Submitted by PANalytical
  • Security PCI Compliance Overview Payment Card Industry (PCI) Compliance is a set of security standards that were created by the major credit card companies (American Express, Discover Financial Services, JCB, MasterCard Worldwide, and Visa International) to protect their customers from increasing identity theft and security breaches. Submitted by Agilence
  • TEDS Releases Compliance And Competencies Case Study On Dominion Resources. By Bersin & Associates' Chris Howard, Principal Analyst. TEDS, originator of the only fully integrated enterprise-wide talent management solution, recently released a case study highlighting the strength of its powerful LMS, Learning on Demand and TEDS RTC Power, a highly robust compliance and competency management tool
  • A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
  • Continuous Flow — An Emerging Alternative

    Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.

  • Focus On Your Core Business Strategy

    Learn how a large manufacturing client helped to focus on their core business with a solution that transitioned approximately 60% of the workforce and capitalized on the initial training investment.

  • Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring

    Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

NEWS