Bioanalytical Services

Bioanalysis is essential for drug development. It transforms complex biological samples into critical data that drug developers and regulatory authorities rely on to evaluate the drug safety, efficacy and compliance. Accurate bioanalytical results are the foundation for successful preclinical and clinical studies.

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At Quality Assistance, we provide fit-for-purpose bioanalytical solutions tailored to your project’s scientific and regulatory requirements. Our expertise in method development, combined with multi-technology capabilities, ensures reliable data at every stage of your (pre)clinical development.

Our services include:

  • Bioanalytical method development and validation
  • Regulated studies for pharmacokinetics and toxicokinetics (PK/TK)
  • Immunogenicity assessment for biologics and biosimilars
  • Biomarker studies

Key bioanalytical services

Method development and validation

  • Development, optimisation and validation of methods (according to EMA/FDA guidelines and ICH M10 expectations)
  • Cross-validation and method transfer
  • Full GLP/GCLP-compliant validation
  • Analyst training and documentation support

Non-clinical study support

  • GLP-compliant PK/PD sample analysis
  • Supportive analysis in vehicles and buffers
  • Biomarker identification and quantification
  • Immunomonitoring and cytokine release assays

Clinical study support

  • GCLP/GCP-compliant sample analysis
  • Biomarker and PK analysis for clinical phases I to III
  • In-use stability studies

Immunogenicity assessment

  • Screening assays for Anti-Drug Antibodies (ADAs)
  • Confirmatory assays to rule out false-positive screening samples
  • Neutralising antibody (NAb) assays
  • Custom development for complex biotherapeutics

Analysis and reporting

  • GLP/GCLP-compliant reporting and deviation management
  • Data integrity and transfer to client databases
  • Comprehensive technical documentation for regulatory submission

We centralise every technology and expertise on a single GxP-certified site. This distinctive model ensures efficiency, consistency, and complete confidentiality across all bioanalytical operations, eliminating inter-site variability and accelerating time-to-results.

We offer end-to-end bioanalytical workflow throughout your entire drug development pipeline

We cover a wide of modalities

Advanced technologies and platforms

All required analytical platforms are available in-house, ensuring full data consistency and no subcontracting:

  • LC-MS/MS
  • HRMS
  • LBA (ELISA, ECL/MSD, Gyrolab, SPR, BLI)
  • Luminex
  • Cell-based assays
  • Flow cytometry
  • ICP-MS

We also develop custom multiplex assays for cytokines and biomarkers. We can safely handle cytotoxic and highly potent compounds on site. We have an extensive experience in analysing biological samples, for all matrices and species;

  • Whole blood, plasma, serum
  • Urine
  • Tissues
  • Tumors
  • Vehicles/Buffers

Why partners choose Quality Assistance?

  • 100% focus on analytical sciences
  • 25 years expertise in bioanalysis
  • EMA & FDA dual expertise ensuring global regulatory compliance
  • Full mastery & implementation of the ICH M10 guidelines ensuring robust and regulatory compliance bioanalytical data
  • Single-site model for faster coordination and one audit for all services
  • Over 40 years of analytical excellence and > 2,000 drug candidates supported
  • High client retention (94%), proof of lasting trust and satisfaction
  • Continuous investment in R&D (10–15% of revenue) to integrate emerging technologies within a GxP environment
  • Dedicated project management ensuring transparent communication and on-time delivery

Our commitment

Behind every dataset lies a patient. Our goal is to transform analytical precision into therapeutic confidence, accelerating access to safe, effective and high-quality medicines.

Get in touch with our team to see how we can help you with your bioanalysis requirements

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