Anacura

life-sciences

Our services

  • Transfer
  • Validation

    Method validation

    • Transferring your identity, purity, quantity, potency & general quality methods for your drug substance & drug product into a controlled, GMP-compliant environment
    • Supporting validation throughout all phases of development (Phase I-III) & commercialization (Phase IV)
    • Covering method review, intake & performance verification over system suitability test establishment to ultimate assessment of method validation parameters such as specificity, linearity, LOQ/LOD, range determination, accuracy, precision, robustness & stability
    • Providing you with a comprehensive validation protocol, report & final validated method
  • Preclinical stress testing
  • Release

    Release & Stability

    • Supporting your GMP release & stability studies for your drug substance & drug product throughout all phases of development (Phase I-III) & commercialization (Phase IV)
    • According to in-house or custom-made procedures & protocols, compliant with regulatory requirements
    • Offering a GMP-compliant & FDA inspected facility, with full traceability by means of our LIMS labware system (from intake, throughout storage according to ICH conditions, to final analysis & reporting), dedicated quality assurance department, cross-functionality trained project teams for maximum project flexibility, and in-house engineering department to support our equipment around the clock
  • Method development

    Method development

    • Delivering a comprehensive set of custom-made, orthogonal methods for identity, quantity, potency, purity & impurity, including product- & process-specific impurities & contaminants to fully monitor product quality at all times.
    • Keeping in mind the objective of each method we provide robust tools with the accuracy & precision required for you to track critical quality attributes (CQAs)
    • Covering each critical aspect of your method through performance verification, including sample preparation, specificity, linearity, LOD/LOQ, range determination, accuracy, precision, recovery & robustness testing
    • Providing you with a comprehensive method development report & final method with method acceptance criteria in line with method performance
  • Forced degradation
  • Consultancy

    Consultancy

    • Listening to your story, understanding your needs & expectations
    • Focusing on the analytics that matter based on our extensive experience
    • Helping you to connect the dots for your product across all aspects of analytics, reviewing historical data, providing scientific interpretations for new results and proposing next steps
  • Stability

Our products

Meet our scientist