REGULATORY SOLUTIONS

• Assess the Safety Profile Of Pharmaceutical Impurities

  Predict Genotoxic & Carcinogenic Endpoints to Meet ICH M7(R2) Guidelines

  ACD/Impurity Profiling Suite predicts a variety of toxicological endpoints to help you assess the genotoxic and carcinogenic potential of impurities and degradants. Developed through a collaborative agreement with the US Food and Drug Administration (FDA), the software can be used as part of your ICH M7(R2) workflow—to help prepare regulatory submissions and remain compliant.

  • Determine the ICH M7(R2) classification for impurities and degradants
  • Predict 21 toxicological endpoints from structure; for mechanisms of hazardous activity including:
    • Mutagenicity (AMES test and other procaryote and eucaryote test systems)
    • Clastogenicity
    • Other DNA damage
    • Carcinogenicity
    • Endocrine disruption mechanisms
  • Identify potentially hazardous structural fragments responsible for carcinogenic and genotoxic activity
  • Gain insight into the possible mechanisms of toxic effects
  • Assess the reliability of predictions
• Assess The Safety Of Pharmaceutical Impurities In Silico

  Advance impurity risk assessment with predictive modeling that clarifies toxicity mechanisms, strengthens regulatory arguments, and reduces experimental burden—helping teams make confident decisions.

• 21 CFR Part 11 Compliance Checklist For A Universal Pump

  This checklist provides a detailed look at the requirements of 21 CFR Part 11 and highlights how the Sterisart® Universal | Gen 4 - Advanced supports your efforts to meet these regulatory demands.

• Sterility Testing For A Connected Era

  This pump combines state-of-the-art hardware with sophisticated, user-friendly software to offer compliant, paperless documentation and reporting.

• Global Experts In Nanotechnology And Drug Particle Engineering

  Discover the nanoparticle engineering, formulation and GMP manufacturing services that can drive forward your market success and unlock the power of “small."

• GxP Compliance Software For Life Sciences (21 CFR Part 11)

  Accelerated GxP and 21 CFR Part 11 compliance without disrupting your existing workflows.

• GxP Document Management For Life Sciences Guide

  Choosing the right document management platform comes with daunting responsibility: compliance, usability, and adoption to name a few. We created this Buyer’s Guide to provide you with a tangible framework to evaluate varied solutions and, ultimately, identify one or more that meet your specific use case.

• Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing

  Life sciences organizations face more pressure than ever to run efficient, uninterrupted manufacturing production at the lowest possible cost. To stay compliant with government regulations, quality and manufacturing organizations must precisely follow Good Manufacturing Practices (GMP) standardized processes and maintain an associated document control process that adheres to those requirements.

• Drug Product Fill Finish And Formulation Solutions

  Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.

• Small Is Powerful, Small Is Green

  As the pharmaceutical industry innovates and evolves, learn more about how Nanoform can play a critical role in empowering your company's journey to net zero.

• EMC Documentum Quality Manufacturing Solution For Life Sciences

  Quality & Manufacturing organizations in Life Sciences companies are facing more pressure than ever to run efficient, uninterrupted production at the lowest possible cost, while meeting stringent safety, quality, and regulatory standards.